Clinical Trials

The following clinical trials are currently being conducted by ECCRI investigators.  For more information on these studies or to refer a patient, please call 404-727-3655 or email eccri@emory.edu.

Emory Cardiovascular Biobank

Sponsor: Emory University

Purpose: Emory Cardiovascualr Biobank is a prospective study of patients who undergo cardiac catheterization for suspected coronary artery disease which investigates the role of novel biomarkers in relation to cardiovascular risk.

Inclusion Criteria:

Patients with active cardiovascular disease including but not limited to
  • Ischemic Heart Disease
  • Heart Failure and Cardiomyopathies
  • Peripheral Vascular Disease
  • Valve disease
  • Adult Congenital Heart disease
  • Electrophysiological Disorders
More information about this study

Study to Investigate CSL112 in Subjects with Acute Coronary Syndrome (AEGIS-II)

Purpose: This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events in subjects with acute coronary syndrome (ACS) diagnosed with either ST-segment elevation myocardia infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), including those managed with percutaneous coronary intervention (PCI) or medically managed.

Inclusion Criteria:

  • Male or female least 18 years of age
  • Evidence of myocardial necrosis, consistent with type I (spontaneous) MI
  • No suspicion of acute kidney injury 
  • Evidence of multivessel coronary artery disease and at least 1 of the following established risk factors: age > 65 years, prior history of MI, diabetes mellitus, or peripheral artery disease.

Evaluation of Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo (CLEAR Outcomes)

Sponsor: Esperion Therapeutics

Purpose: The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus placebo decreases the risk of cardiovascular events in patients who are statin intolerant.

Inclusion Criteria:

  • Age between 18 and 85 years
  • History of, or at high risk for, cardiovascular disease (CVD) including coronary artery disease, symptomatic peripheral arterial disease, cerebrovascular atherosclerotic disease, or at high risk for a cardiovascular event
  • Patient reported history of statin intolerance (inability to tolerate 2 or more statins, one at a low dose)
  • Men and nonpregnant, nonlactating women
  • Fasting blood LDL-cholesterol between 100 and 190 mg/dL at screening

Exclusion Criteria:

  • Fasting blood triglycerides greater than 500 mg/dL at screening
  • Recent history of certain cardiovascular disease including transient ischemic attack (TIA), unstable or symptomatic cardiac arrhythmia, use of an implantable pacemaker or implantable cardioverter defibrillators, or coronary revascularization procedure
  • History of heart failure
  • Uncontrolled hypertension

A Double-blind, Randomized, Sham–procedure–controlled, Parallel-group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (rexlemestrocel-L) in Patients with Chronic Heart Failure Due to Left Ventricular Systolic Dysfunction of Either Ischemic or Nonischemic Etiology: DREAM HF-1

Sponsor: Mesoblast, Ltd.

Purpose: The purpose of this study is to evaluate the efficacy and safety of a single transendocardial delivery in the cardiac catheterization laboratory of human bone marrow-derived allogeneic MPCs (rexlemestrocel-L) for improvement in clinical outcomes (HF-MACE), preventing further adverse cardiac remodeling (LVESV and LVEDV), and increasing exercise capacity (6MWT) in patients with chronic HF due to LV systolic dysfunction of either ischemic or nonischemic etiology who have received optimal medical/revascularization therapy.

This study is no longer recruiting.

Granulocyte Macrophage Stimulating Factor (GM-CSF) in Peripheral Artery Disease

Sponsor:  NIH: NHLBI

Purpose:  This study is investigating whether GM-CSF (granulocyte-macrophage colony stimulating factor or Sargramostim) improves symptoms and blood flow in people with Peripheral Artery Disease (PAD).

Inclusion Criteria:

  • Angiographically documented PAD.
  • Clinically stable (>2 months) history of intermittent claudication or walking impairment (Rutherford Class II) with no change in symptom severity in the 2 months prior to screening.
  • On stable statin therapy for previous 3 months.
  • Peak Walking Time (PWT) between 1 and 12 minutes on a standardized Gardner treadmill protocol. 
  • A Doppler-derived ankle-brachial index (ABI) of < 0.90 in the symptomatic limb after 10 minutes of rest at screening.  For subjects with an ABI of >1.3 (non-compressible arteries) a Toe-Brachial Index (TBI) of < 0.70 must be obtained for subject qualification, or if ABI is > 0.9 to 1.0 , and a reduction of 20% in ABI measured within 1 minute of treadmill testing. 
  • On appropriate and stable medical therapy for atherosclerosis for > 2 months.

More information about this study

Cardiovascular Health and Resilience among Blacks: The Morehouse-Emory Cardiovascular (MECA) Center for Health Equity Study

Sponsor: American Heart Association

Purpose: The purpose of this study is to investigate the factors that lead to increased risk or resilience to cardiovascular disease, specifically within African American communities in Atlanta. The study has three major projects. First, risky and resilient communities in the greater Atlanta area will be determined using publicly-available demographic and hospitalization data. Next, individuals from these communities will be called and asked to participate in multiple surveys that will further characterize their health, personal beliefs and community characteristics. Finally, a small group of individuals from these phone calls will participate in further clinical testing to determine their degree of blood vessel disease.

Inclusion Criteria:

  • Self-identified Black or African-American race/ethnicity
  • Age 30-65
  • Living in the greater Atlanta area with a working telephone
  • Reside in a census tract area designated as “at risk” or “resilient”

 

Mental Stress Ischemia - Mechanisms and Prognosis

Sponsor: National Institutes of Health

Purpose: The NIH-funded Mental Stress Ischemia Study is the first comprehensive attempt to clarify pathophysiology of mental stress ischemia (MSI) and its prognosis. The study’s 3 projects examine brain, genetic, vascular, hormonal, and behavioral correlates of MSI and their influence on future cardiac events.  

Project 2, Aim 2 (the “Cath-Lab Sub-study”) attempts to evaluate the relationship between mental stress and arterial wall shear stress, endothelial function and atherosclerosis.

Patients with history of angiographically-proven or suspected Coronary Artery Disease (age 30 - 80) undergoing a clinically indicated diagnostic heart catheterization are invited to participate in the study.

In addition to standard diagnostic angiography, a wire will be placed inside an unblocked coronary artery to measure blood flow before and after mental stress (using standardized mental stress testing scenarios) as well as following infusion of intracoronary acetylcholine, adenosine and nitro. An intravascular ultrasound  is used to assess plaque characteristics/severity of any blockages and help calculate wall shear stress. This test will add about 20-30 minutes to your angiogram procedure.

Inclusion Criteria:

  • Age: Between 30 and 80 years old (Must have at least 1 of the criteria 2-6)
  • Angiographically proven disease including at least 1 major vessel with evidence of disease but with no specific minimum lumen diameter criteria
  • Previous myocardial infarction (>1 month) documented by typical elevation of enzymes, pain or ECG changes
  • Abnormal coronary intravascular ultrasound exam (IVUS) demonstrating atherosclerosis of at least 1 vessel
  • Post coronary bypass surgery or percutaneous intervention (>1 year after complete revascularization)
  • Positive nuclear scan or stress exercise test

Mental Stress Ischemia: Biofeedback Study (MIBS)

Purpose: The purpose of this study is to evaluate the blood flow to the heart during stress and assess changes in blood flow after psychological treatment in participants with coronary artery disease. This is a randomized controlled study. The aims of the study are to assess the effects of heart rate variability (HRV) biofeedback (versus usual care) on global and regional myocardial blood flow (MBF), peripheral vascular function, and autonomic changes during mental stress.

All participants will undergo myocardial flow/perfusion imaging with positron emission tomography (PET) imaging at rest and after a standardized arithmetic mental stress test. Participants will then undergo repeat testing after 6 weeks. At 12 weeks, participants will also undergo a limited examination without myocardial perfusion imaging. The intervention group will receive biofeedback after enrollment, and the wait-list control group will receive the intervention between week 6 and week 12 study visits (without imaging).

Inclusion Criteria: 
Prior participation in the Mental Stress Ischemia: Mechanisms and Prognosis (MIPS) study

Smartphone Delivered In-home Cardiopulmonary Rehabilitation

Purpose: The goal of this study is to determine if a remote cardiac or pulmonary rehabilitation program delivered via a smartphone application and regular telephone calls will lead to improved patient outcomes as measured by functional capacity, improved patient compliance in monitoring symptoms and medication adherence, improved self-efficacy and knowledge in managing disease and, a decreased rate of hospitalization and re-admissions.

Inclusion Criteria: 

  1. Following acute myocardial infarction (within the preceding 12 months)
  2. Coronary artery bypass grafting (CABG)
  3. Current stable angina pectoris
  4. Heart valve repair or replacement
  5. Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting
  6. Heart or heart-lung transplant
  7. Other diagnosis by specific physician referral

Smartphone-Enabled Supervised Exercise Therapy for the Treatment of Symptomatic Peripheral Arterial Disease

Purpose: The study aim is to evaluate the effectiveness of a coached, smartphone-enabled exercise program versus physician directed exercise therapy (usual care).

Inclusion Criteria:
•Clinically stable intermittent claudication
•Able to give informed consent
•Age 18-89 years

And one of the following:
•ABI < 0.9 after 10 minutes of rest OR
•For subjects with an ABI of >1.3 (non-compressible arteries) a Toe-Brachial Index (TBI) of < 0.70 must be obtained for subject qualification. If ABI is > 0.9 to 1.0, a reduction of 20% in ABI must be measured within 1 minute of treadmill testing.