Community-based clinical trials are a vital element of the comprehensive heart care available at Piedmont Hospital's Fuqua Heart Center. Multiple clinical trials are underway at the Fuqua Heart Center at any given time. Presently, we are recruiting patients for trials studying the next generation of drug-eluting stents, diabetes and cardiovascular disease, renal stenting, management of advanced coronary artery disease (CAD), congestive heart failure, genomics, post-MI pacing for remodeling prevention, and multiple other device and medical therapy studies. Current comprehensive clinical trials involve the National Institutes of Health (NIH), the pharmaceutical industry, along with investigator-initiated and collaborative research projects with the country's leading research centers.
The clinical trials currently open are listed below by disease type.
If you are a patient and would like additional information on research and clinical trials, please visit
Information for Patients.
If you are a health care provider and would like additional information on a clinical trial or would like to refer a patient for a study, please visit
Information for Physicians. Acute Coronary Syndrome (ACS)/Unstable Angina
ARRHYTHMIA
Title of Study: Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT) Clinical Investigation
Study Summary:
The purpose of this study is to determine if Cardiac Resynchronization Therapy (CRT) can prevent death or reduce heart failure hospitalizations for patients who have dyssynchrony on an echocardiogram, but don't have the delayed pulse conduction on an ECG. CRT provides pacing therapy (small electrical impulses) that stimulate both the right and left side of the heart to improve the heart's ability to pump blood throughout the body.
Treatment:
All patients receive a CRT system during a surgical procedure, which is the same procedure as for any CRT system. After the device is implanted, patients will be randomly assigned to have their device programmed as follows:
CRT function turned on
OR
CRT function not turned on
Follow-up visits occur one (1) month after the procedure and every three (3) months thereafter for up to 24 months (2 years). After the 24-month visit, they will return every three (3) months for standard follow-up visits to evaluate the device and heart failure status until the study is over.
Supported by: Biotronik
Principal Investigator: Dan Dan, MD
Contact: For more information, please call 404-605-2409 or email
phri@piedmont.org
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Title of Study: ALERTS: Angelmed for Early Recognition and Treatment of STEMI
Study Summary:
The main purpose of this study is to compare the safety and effectiveness of the Angel Medical Guardian System with the standard of care in the treatment of patients at high risk of heart attacks. The tests that will be done will evaluate the Guardian System's ability to monitor the heart's signal and accurately detect any abnormalities that might indicate a heart attack - and to properly alert the patient to seek medical attention.
Treatment:
All patients will be implanted with the Guardian IMD. At the 7-14 days after implant, patients will be randomized into one of two study groups:
Control Group
If randomized to this group, the device will have the Guardian System Alerts turned "OFF." The patient's heart condition will be treated per standard of care. The implanted device will monitor the heart but will not alert the patient to any abnormal heart signals or problems that prevent the device from working properly. After 6 months of being enrolled in the study, the patient will have the alerting turned "ON" and be trained on the use of the Guardian System and identification of and response to alarms.
Treatment Group
If randomized to this group, the device will have the Guardian System Alerts turned "ON." The device will monitor the heart condition and the patient will be alerted to any abnormal heart signals or problems that prevent the device from working properly. After implant the patient will undergo training on the use of the Guardian System and identification of and response to alarms.
Follow-up visits will occur 7-14 days after surgery, at 1, 3, and 6 months, and every 6 months thereafter, as long as the patient has their device (approximately 3-4 years or as often as the treating physician decides).
The patient's participation in the study is expected to last approximately 24 months.
Supported by: Angel Medical Systems
Principal Investigator: Andrew Wickliffe, MD
Contact: For more information, please call 404-605-2409 or email
phri@piedmont.org
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Title of Study: Discern: Identifying Markers that Predict Arrhythmia Risk in Patients with Heart Failure
Study Summary:
The purpose of this study is to examine the hereditary basis of cardiac arrhythmia in patients with heart failure (HF), to relate these factors to the cause(s) of cardiac arrhythmias, and to use this information to design and develop new tests for the diagnosis and treatment of arrhythmias.
Treatment:
All subjects will have three tablespoons of blood drawn from a vein in their arm or sheath in the groin and they will also contribute a saliva sample. Subject's medical history, lab test results, and device activity will also be collected at baseline and follow-up over 2 years. These tests will be used for genetic studies to predict arrhythmia risk.
Supported by: CardioDx, Inc
Principal Investigator: Szilard Voros, MD
Contact: For more information, please call 404-605-2409 or email
phri@piedmont.org
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Title of Study: MAGELLAN - A Randomized Controlled Trial of Radiofrequency Ablation for the Treatment of Paroxysmal Atrial Fibrillation Using the BARD High Density Mesh Ablation System
Study Summary: The purpose of this study is to evaluate the safety and effectiveness of a special kind of RF ablation device, the Bard HD Mesh Ablation System (HDMA), an investigational medical device, in treating PAF.
Randomization:
Patients who meet enrollment criteria will be randomized to one of two treatments:
Group 1: Ablation procedure using the HDMA
OR
Group 2: Anti-arrhythmic drug treatment
Follow-up visits will occur in the physician office at 1, 3, 6, and 12 months after they start taking the drug or received the ablation procedure, for a total of 4 visits.
Study participation is expected to last 12-15 months.
Support provided by: Bard Electrophysiology, C.R. Bard, Inc.
Principal Investigator's: Dan Dan, MD
Contact: For more information, please call 404-605-2409 or email
phri@piedmont.org
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Title of Study: NATURE: NATURal Evolution of AV Conduction Disorders in Patients Implanted with Cardiac Pacemakers
Study Summary:
The primary objective is to measure the incidence of high-degree atrio ventricular block (AV block) in Sinus Dysfunction and Brady Tachy Syndrome population through a two (2) year follow up.
Treatment:
This is an observational study, which means that the patient will not undergo any additional procedures or physician visits because they are participating in this study. The pacemaker that the physician selected for implantation and treatment enables a variety of information about how the heart is functioning to be recorded in the memory of the device. Participating in this study will allow the physician to obtain the information normally stored in the pacemaker's memory. This information will be collected during the patient's regularly scheduled follow-up visits with their physician.
In addition to the information automatically stored in the pacemaker, the physician will collect information related to the patient's current medications, information about why the patient needed a pacemaker, and any medical issues the patient may experience during the time they participate in the study.
Data will be collected from the implant procedure and at routine follow-up visits for a period of two (2) years. No study-related visits are required.
Supported by: ELA Medical, Inc. (SORIN Group)
Principal Investigator: Andrew Wickliffe, MD
Contact: For more information, please call 404-605-3561 or email
phri@piedmont.org
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Title of Study: SMARTDELAY determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy
Study Summary:
The purpose of this study is to evaluate how different methods for determining the programming of a CRT-D device affect the heart. All the methods tested in this study have been proven to be effective. This study will examine which of the three is the most effective.
Treatment:
After the device is implanted, patients will be randomly assigned to have their device programmed by one of the following three methods.
Using a standard preset setting in the CRT-D device
OR
Using measurements taken by the CRT-D device
OR
Using echocardiography (an ultrasound of the heart that shows moving pictures of the heartbeat)
Participation in this study will last approximately 6 months.
Support provided by: Boston Scientific Corporation
Principal Investigator: Dan Dan, MD
Contact: For more information, please call 404-605-2409 or email
phri@piedmont.org
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CORONARY
Title of Study: Africa: Atorvastatin Plus Fenofibric Acid (TriLipix) in the Reduction of Intermediate Coronary Atherosclerosis
Study Summary:
This study will examine how TriLipix, when used in combination with a statin, affects the makeup of plaque as measured by coronary artery CTA.
Treatment:
AAll patients will be randomly assigned to receive one of the two following treatments:
Group 1: TriLipix
OR
Group 2: Placebo (pills that contains no active treatment)
Visits 1 and 2 are screening visits where patients will give blood, receive dietary counseling and other lifestyle changes for heart-healthy living, have a coronary artery CTA (Visit 2 only), and will receive one of the study medications.
If the patient is found to be eligible, the remaining visits, up to 18 months of treatment, will be spaced 3 months apart and will consist of a blood draw, dietary counseling, and review of usage and continuation of study medication. At the last visit, the patient will have another coronary artery CTA.
The coronary artery CTA and study medications are provided to the patient free of charge.
Support provided by: Piedmont Hospital and Abbott Laboratories
Principal Investigator: Szilard Voros, M.D.
Contact: For more information, please call 404-605-2958 or email
phri@piedmont.org
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Title of Study: ATLANTA II: Validation of Stenosis Assessment by Coronary Artery Computed Tomography Against Invasive Measurements of Fractional Flow Reserve in Patients With Significant Coronary Artery Stenosis
Study Summary:
The purpose of this study is to evaluate the effectiveness of CorCTA by comparing the results of the test with other invasive imaging methods, which are done as part of the cardiac catheterization. CorCTA is a non-invasive method that uses advanced technology (multiple x-ray images) to obtain extremely detailed, three-dimensional images of the heart and vessels. It has the potential to identify atherosclerosis at an earlier stage, when it is most easily treated.
Treatment:
All patients enrolled on study will undergo a CorCTA prior to the clinically indicated cardiac catheterization procedure. The cardiac catheterization procedure will include a Fractional Flow Reserve (FFR), Intravascular Ultrasound (IVUS), Virtual Histology (VH) or some combination of these three procedures.
Participants will also be asked to donate a blood sample for genetic testing related to coronary artery disease.
Follow-up consist of a telephone call 12 months after enrollment.
Support provided by: Piedmont Hospital and Abbott Vascular
Principal Investigator: Szilard Voros, MD
Contact: For more information, please call 404-605-3074 or email
phri@piedmont.org
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Title of Study: RESOLUTE US - A Clinical Evaluation of the Medtronic Endeavor® Resolute Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries with a Reference Vessel Diameter of 2.25 mm to 4.2 mm.
Study Summary:
The purpose of this study is to evaluate if the new Endeavor Resolute stent using the new polymer is safe and how effective the drug-eluting stent is in reducing the renarrowing in coronary arteries over time.
Randomization:
Every patient who wishes to participate and meets the eligibility criteria will be eligible to receive the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System (referred to as the Endeavor Resolute stent) for their stenting procedure. The size of the stent received will depend on the size of the blood vessel being treated.
Schedule:
If a patient meets the eligibility requirements for the study and wishes to participate they will have a screening visit. The patient will then have assessments done 7 days and 72 hours prior to the procedure. They will have assessments during the procedure, post procedure and at 30 days, 6, 9, 12 and 18 months post procedure and then annually beginning at 2 years post procedure, for 5 years after the procedure (4 annual contacts). These assessments will either be conducted at the study clinic (at 30 days, 8 months for patients receiving a large sized stent and 9 month visits) or patient contact via email or over the telephone, whichever is deemed appropriate by the study physician per protocol at 6 months, 12 months, 18 months and 2-5 Years.
Study participation is expected to last 5 years.
Supported by: Medtronic Vascular
Principal Investigator: Charles L. Brown, III, MD
Contact: For more information, please call 404-605-2301 or email
phri@piedmont.org
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Title of Study: TRACER: A Multi-center, Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With Acute Coronary Syndrome: Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome
Study Summary:
The primary objective of this study is to evaluate whether SCH 530348, when added to standard of care, will reduce the incidence of atherothrombotic ischemic events compared to standard of care alone.
Treatment:
Subjects will be randomized to one of two groups:
Treatment with the study drug (SCH530348) taken as a pill once a day for one year
OR
Treatment with a placebo (a pill that contains no active drug) taken as a pill once a day for one year
Administration of study drug will begin one hour before the procedure. After the procedure, the study drug will be provided to the subject to be taken daily. Follow-up visits will occur at 30 days after the procedure and then at 4, 8, and 12 months after starting the study drug. After the first year, follow-up will be every 6 months until the study is completed.
Supported by: Schering-Plough Research Institute
Principal Investigator: Charles L. Brown, MD
Contact: For more information, please call 404-605-3752 or email
phri@piedmont.org
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Title of Study: Protection AMI: Inhibition of ?-PROTEin kinase C for the reducTION of infarct size in Acute Myocardial Infarction
Study Summary:
The main purpose of this study is to determine whether KAI-9803 (an investigational drug) can reduce the amount of heart muscle damage and the complications that can occur in patients who have an angioplasty for their heart attack.
Treatment:
Patients are randomly assigned to one of four treatment groups, and will receive either various doses of KAI-9803 (active drug) or a placebo (inactive substance) as an intravenous infusion (infusion into the vein) starting before the angioplasty procedure and continuing for approximately 2 ½ hours.
Follow-up visits or telephone calls will occur at 1, 3, 6, and 12 months after the angioplasty procedure.
Support provided by: KAI Pharmaceuticals, Inc. and Bristol-Myers Squibb
Principal Investigator: Charles Wilmer, MD
Contact: For more information, please call 404-605-3752 or email
phri@piedmont.org
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Title of Study: FREEDOM: Future Revascularization Evaluation in Patients With Diabetes Mellitus: Optimal Management of Multivessel Disease.
Study Summary:
The purpose of this study is to compare two different methods of treatment for patients with diabetes mellitus and coronary artery disease in more than one heart vessel: (1) Coronary artery bypass surgery (CABG, also called open heart surgery), which is standard of care and (2) Drug-eluting coronary stents (metal devices). Specifically, this study is designed to evaluate whether drug-eluting stenting is more or less effective than CABG.
Treatment:
Participants will be randomly assigned to one of the two following groups:
Group 1: CYPHER sirolimus-eluting stent or TAXUS paclitaxel-eluting stent
OR
CABG
Follow-up visits will occur at 30 days after the initial procedure and then each year for a minimum of 2.5 years, but possibly up to 6.75 years. There will also be semi-annual telephone follow-ups starting at 6 months.
Support provided by: National Heart, Lung and Blood Institute (NHLBI)
Co-Principal Investigators: William Ballard, MD, David Robertson, MD, and James Kauten, MD
Contact: For more information, please call 404-605-3752 or email
phri@piedmont.org
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Title of Study: PREDICT: Identification of Gene Expression Patterns in Circulating Cells that Predict the Presence of Coronary Artery Disease
Study Summary:
The intent of this study is to generate information about whether the biological behavior of blood cells reflects the presence of CAD in the heart, and to use this information to design and develop new tests for the diagnosis of CAD using a simple blood sample.
Treatment:
Each patient enrolled on this study will have about 3 to 3½ tablespoons of blood drawn from the sheath (tube) that is inserted into the groin during the catheterization, or from a vein in the arm. The blood will be analyzed for genetic materials (RiboNucleic Acid (RNA) and DeoxyriboNucleic Acid (DNA)), and proteins. The results of studies on the blood will be compared to the findings of the catherization and/or CTA images that are being performed as part of the patient's clinical care.
Follow-up will consist of contact by mail or phone 6 months and 1 year after enrollment to discuss the patient's health status.
Support provided by: CardioDx, Inc.
Principal Investigator: Szilard Voros, MD
Contact: For more information, please call 404-605-2301 or email
phri@piedmont.org
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HEART FAILURE
Title of Study: A Study of the Evalve® Cardiovascular Valve Repair System (CVRS)
Study Summary:
The purpose of the study is to evaluate an investigational device and compare it to traditional heart surgery to replace or repair the mitral valve. The device is called the Cardiovascular Valve Repair System (CVRS). It consists of a delivery catheter and an implantable Clip to repair the mitral valve. The delivery catheter guides the Clip into place so that it can be attached to the leaflets of your mitral valve. Once the Clip is in place on the mitral valve, the delivery catheter is removed. The information collected in this study will be used to evaluate how well patients do immediately after the procedure when treated with CVRS or surgery, and how effective the device is in treating MR.
Treatment:
Patients will be randomly assigned to one of two groups:
Group 1: Treatment with the Cardiovascular Valve Repair System (CVRS)
OR
Group 2: Cardiac Surgery
Patients will be randomly assigned (at a 2 to 1 ratio) to undergo treatment with the CVRS or undergo cardiac surgery. There is a 2 out of 3 chance that the patient will be assigned to the CVRS treatment or a 1 out of 3 chance that they will be assigned to the surgery group. If the patient is assigned to the surgery group, they will undergo cardiac surgery for their MR.
Follow-up visits will occur at 30 days, 6, 12, 18 and 24 months. Additional visits will continue once a year until the required number of patients have been enrolled in the study and followed for up to twelve months. This could continue for up to five years.
Supported by: Evalve, Inc.
Principal Investigator: Vivek Rajagopal, MD
Contact: For more information, please call 404-605-3752 or email
phri@piedmont.org
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Title of Study: CHAMPION HF: CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
Study Summary:
The objective of the study is to evaluate the safety and efficacy of the HF Pressure Measurement System in reducing heart failure (HF) related hospitalizations in a subset of subjects suffering from HF.
Treatment:
Patients will be randomized to receive standard of care HF management or standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System in a 1:1 ratio.
Subjects will have follow-up visits at months 1, 3, 6, 12,18, 24, 30, and 36
Supported by: CardioMEMS, Inc.
Principal Investigator: Vivek Rajagopal, MD
Contact: For more information, please call 404-605-2371 or email
phri@piedmont.org
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IMAGING
Title of Study: APC: Atherosclerotic Plaque Characterization Using Multispectral, Multicontrast High Resolution Cardiovascular Magnetic Resonance Imaging.
Study Summary:
The purpose of this study is to examine what elements makeup plaque that is found in the carotid walls of patients who have atherosclerosis. The study will also evaluate the effectiveness of magnetic resonance imaging (MRI) in identifying these plaque characteristics. This will be done by comparing the MR images with tissue and/or blood samples collected during the carotid endarterectomy and/or an office visit.
Treatment:
Patients may participate in this study in one of three ways:
1) Donate a tissue sample from the carotid vessel during a carotid endarterectomy.
2) Have a MRI of the heart.
3) Donate a tissue sample from the carotid vessel and have a MRI of the heart.
All patients will also donate a blood sample for analysis.
Support provided by: Piedmont Hospital
Principal Investigator's: Szilard Voros, MD
Contact: For more information, please call 404-605-3074 or email
phri@piedmont.org
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PERIPHERAL VASCULAR
Title of Study: ORION - A Boston Scientific Study of the EPIC
TM Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries
Study Summary:
The purpose of this study is to see if the EPIC
TM Nitinol Stent System is safe and effective for opening blocked or narrowed iliac arteries.
Treatment
All patients who wish to participate and meet the eligibility criteria will receive the EPIC
TM Nitinol Stent System. Follow-up office visits will occur at one (1) month, nine (9) months and one (1) year after the procedure. They will be contacted by phone at two (2) and three (3) years after the procedure for protocol required assessments.
Supported by: Boston Scientific Corporation
Principal Investigator: Bhagat K. Reddy, MD
Contact: For more information, please call 404-605-3819 or email
phri@piedmont.org
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Title of Study: CABANA: A Carotid Stenting Boston Scientific Surveillance Program
Study Summary:
Although the Carotid WALLSTENT
® Monorail
® Endoprosthesis (stent) and FilterWire EZ
TM Embolic Protection System have been approved by the FDA, the manufacturer of the devices (Boston Scientific) has been asked by the FDA to continue to collect additional information about the stent and embolic protection system, details of the stenting procedure and information about patients treated with the stent.
Treatment
All patients will undergo the stenting procedure according to their doctor's usual practice. Patients will return to their doctor for a 30-day follow-up visit (23 to 37 days after the procedure).
The patient's participation in this study will last approximately 30 days
Supported by: Boston Scientific Corporation
Principal Investigator: Bhagat Reddy, MD
Contact: For more information, please call 404-605-3819 or email
phri@piedmont.org
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Title of Study: STROLL: S.M.A.R.T.
TM Nitinol Self-Expandable Stent in the Treatment of Obstructive Superficial Femoral Artery Disease
Study Summary:
Superficial femoral artery (SFA) is a narrowing (stenosis) of one of the main arteries in the leg resulting in poor blood flow to the muscles. This narrowing may be treated by dilating (expanding) it with a balloon. This procedure is called Percutaneous Transluminal Angioplasty, or PTA. However, in some cases the artery becomes narrow again within months or years. The S.M.A.R.T.
TM Nitinol Stent System has previously been approved for use in the iliac arteries (the arteries that supply most of the blood to the lower limbs and pelvic region), but not for the superficial femoral artery. The S.M.A.R.T.
TM stent is the investigational stent that will be used and evaluated in this study. The purpose of this study is to determine if the S.M.A.R.T.
TM stent is as safe and effective as other stents used in the treatment of Obstructive SFA Disease.
Treatment:
All patients will have the S.M.A.R.T.
TM stent implanted in the narrowed section of their superficial femoral artery. After the procedure, patients will be required to visit their physician for certain evaluations and tests at one month, six months, and once each year for up to five years after the procedure.
Throughout the study, patients will be asked to complete a questionnaire about how their symptoms impact your day-to-day life.
This study also contains a health economics review that will be done to evaluate the medical care costs for patients with SFA treated with the S.M.A.R.T.
TM stent.
Supported by: Cordis Corporation
Principal Investigator: Bhagat Reddy, MD
Contact: more information, please call 404-605-3819 or email
phri@piedmont.org
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Title of Study: CHOICE: Carotid Stenting for High Surgical Risk Patients; Evaluating Outcomes Through the Collection of Clinical Evidence
Study Summary:
The purpose of this study is to collect data about patients' medical experiences and conditions following treatment of carotid stenosis using one of Abbott Vascular's carotid stent systems and embolic protection systems.
Treatment:
All patients will receive a stent using an embolic protection system to treat a blockage (stenosis) in the carotid artery. The study-related activities consist of collecting information about the patient's medical condition during the first 30 days after the carotid stenting procedure. Patients will undergo a neurological evaluation and related testing 30 days after the procedure.
Support provided by: Boston Scientific Corporation
Principal Investigator: Bhagat Reddy, MD
Contact: more information, please call 404-605-3819 or email
phri@piedmont.org
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Title of Study: CORAL: Cardiovascular Outcomes in Renal Atherosclerotic Lesions Randomized and Multi-Center Two-Group Clinical Trial to Assess the Best Treatment for Patients With High Blood Pressure and Renal Artery Stenosis: Stenting With Anti-Hypertensive Medical Therapy, Compared to Medical Therapy Alone.
Study Summary:
This study is designed to compare the safety and effectiveness of treating renal artery stenosis with the use of an investigational device and blood pressure medication as compared to blood pressure medication alone. The device is called the PALMAZ GENESIS Stent (a stainless steel mesh tube that is permanently implanted) to keep the kidney artery open allowing more blood to flow to the kidney.
Treatment:
Patients who are identified as eligible for the study will randomly assigned to one of the two following groups:
Group 1: PALMAZ GENESIS stent + medical therapy (blood pressure medication)
OR
Group 2: Medical therapy alone
The patient's doctor will be able to decide what type of blood pressure medications the patient should take. The patient's doctor also can change these medications as often as he/she thinks they should be changed.
Follow-up visits will occur at 2 weeks, 3 three months and 6 months after randomization. After the first year, the patient will see their study doctor or study nurse twice a year (every six months) until the study is completed.
Support provided by: National Heart, Lung and Blood Institute
Principal Investigator: Bhagat Reddy, MD and Edward Frederickson, MD
Contact: more information, please call 404-605-3819 or email
phri@piedmont.org
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PREVENTION
Title of Study: Decide CTA: Prospective Detection of Subclinical Atherosclerosis in Asymptomatic Individuals with High Likelihood of Coronary Artery Disease with a Novel, Low-Radiation Volumetric Computed Tomography Approach
Study Summary:
This study will evaluate the use of cardiac CT in identifying atherosclerosis plaque in patients who have not been diagnosed with atherosclerosis and who have no symptoms of the disease but who are at risk of developing atherosclerosis based on traditional risk factors such as diabetes or a family history of coronary artery disease.
Treatment:
All participants will undergo a coronary artery CT angiogram with a contrast agent at the time of enrollment. Participants will also be asked to donate a blood sample for genetic analysis and lipid profiling. The blood sample is optional.
Follow-up will occur 6 months after enrollment and will consist of a telephone inquiry about any health problems experienced since enrollment on the study. At one year, participants will return for a second CT to evaluate any changes in their disease status.
Support Provided by: Piedmont Healthcare and Toshiba
Principal Investigator: Szilard Voros, MD
Contact: more information, please call 404-605-3074 or email
phri@piedmont.org
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Title of Study: CGR: CAD Genotype and Phenotype Cardiac Catheterization Laboratory Registry
Study Summary:
The main purpose of this study is to investigate the interaction of multiple phenotypes and genotypes and their impact on cardiovascular disease events and measures of atherosclerosis progression.
Treatment:
Patients who agree to enroll on this study will donate a blood specimen. The specimen is collected either through the catheter that is placed in the patient's groin for their procedure or by a needle inserted into a vein in their arm. The sample will be about 20 mL of blood, which is about 4 teaspoons.
There are no follow-up visits associated with this study.
Support Provided by: Piedmont Hospital
Principal Investigator: Szilard Voros, MD
Contact: more information, please call 404-605-3074 or email
phri@piedmont.org
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SURGERY
Title of Study: Red-CABG: The Effect Of Acadesine On Clinically Significant Adverse Cardiovascular and Cerebrovascular Events In High-Risk Subjects Undergoing Coronary Artery Bypass Graft (CABG) Surgery Using Cardiopulmonary Bypass: RED-CABG Trial (Reduction in Cardiovascular Events by AcaDesine in Subjects Undergoing CABG)
Study Summary:
The goal of the study is to evaluate the benefits of the study drug in reducing the risk of death, severe left ventricular dysfunction (SLVD) and stroke (cerebral vascular event) up to 28 days after coronary artery bypass graft (CABG) surgery. It could also reduce other morbidities, length of hospital stay, and associated costs. The study will also evaluate the safety of the drug.
Treatment:
All participants will be randomly assigned to receive one of the two following treatments:
Group 1: Acadesine
OR
Group 2: Placebo
Participants will receive the study drug or placebo just before the anesthesia is administered and for 7 hours during and/or immediately after the operation.
Follow-up will consist of a 28-day clinic visit and a 6 month telephone contact.
Support Provided by: Schering-Plough Research Institute
Principal Investigator: William Morris Brown, M.D.
Contact: more information, please call 404-605-3752 or email
phri@piedmont.org
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