Clinical Trials

Listed below are clinical trials being conducted by principal investigator, Arshed A. Quyyumi, MD.  For more information on these studies or to refer a patient, please call 404-727-3655 or email eccri@emory.edu.

 

See recently completed clinical trials here.

Cardiovascular Biobank

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
Healthy volunteers age 18 or above.

CLEAR Outcomes

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:

  • 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

GPAD 3

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.

MECA

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

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 specifi c 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

PROMINENT

Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes 

Sponsor: Kowa Research Institute, Inc.

Purpose: The primary objective of the study is to determine whether pemafibrate administered twice daily will delay the time to first occurrence of any component of the clinical composite endpoint of:

  • nonfatal Myocardial Infarction (MI)
  • nonfatal ischemic stroke
  • hospitalization for unstable angina requiring unplanned coronary revascularization; or
  • Cardio Vascular (CV) death.

Inclusion Criteria:

  1. Fasting TG ≥ 200 mg/dL (2.26 mmol/L) and < 500 mg/dL (5.65 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)
  2. HDL-C ≤ 40 mg/dL (1.03 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)
  3. Type 2 diabetes of longer than 12 weeks duration documented in medical records, for example: local laboratory evidence through medical record review of elevated HbA1c (≥ 6.5% [48 mmol/mol]), elevated plasma glucose (fasting ≥ 126 mg/dL [7.0 mmol/L], 2-hour ≥ 200 mg/dL [11.1 mmol/L] during oral glucose tolerance testing, or random value ≥ 200 mg/dL with classic symptoms, or currently taking medication for treatment of diabetes; AND either

    1. Age ≥ 50 years if male or ≥ 55 years if female (primary prevention cohort); OR
    2. Age ≥ 18 years and established systemic atherosclerosis (secondary prevention cohort), defined as any 1 of the following:

      • i. Prior MI or ischemic (non-hemorrhagic) stroke
      • ii. Coronary angiographic lesion of ≥ 60% stenosis in a major epicardial vessel or ≥ 50% left main stenosis
      • iii. Asymptomatic carotid disease with ≥ 70% carotid artery stenosis
      • iv. Symptomatic carotid disease with ≥ 50% carotid artery stenosis
      • v. Symptomatic lower extremity PAD (ie, intermittent claudication, rest pain, lower extremity ischemic ulceration, or major amputation with either ankle-brachial index ≤ 0.9 or other diagnostic testing [eg, toe-brachial index, angiogram, or other imaging study])
      • vi. Prior arterial revascularization procedure (including coronary, carotid, or peripheral angioplasty/stenting, bypass, or atherectomy/endarterectomy)

TEVA C41750/3100 (DREAM-HF)

A Double-blind, Randomized, Sham–procedure–controlled, Parallel-group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (CEP–41750) in Patients with Chronic Heart Failure Due to Left Ventricular Systolic Dysfunction of Either Ischemic or Nonischemic Etiology

Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Purpose: The primary objective of this study is to determine whether transendocardial delivery of allogeneic human bone marrow-derived MPCs (CEP-41750) is effective in the treatment of chronic heart failure due to LV systolic dysfunction.

Inclusion Criteria: 

  • The patient is 18 to 80 years of age, inclusive; both men and women will be enrolled.
  • The patient has a diagnosis of chronic HF of ischemic or nonischemic etiology for at least 6 months
  • The patient is on stable, optimally tolerated dosages of HF therapies including beta-blockers (approved for country-specific usage), angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), and/or aldosterone antagonists, without change in dose for at least 1 month before study intervention
  • The patient is on a stable, outpatient, oral diuretic dosing regimen in which the patient remains clinically stable during screening.
  • Other Criteria apply, please contact the investigator

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)

Inclusion Criteria:

  • 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