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 contact Salman Sher at ssher2@emory.edu or 404-712-0170. 

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.

GAUSS-3

Goal Achievement after Utilizing an anti-PCSK9 antibody in Statin Intolerant Subjects

Sponsor: Amgen, Inc.

Purpose: The primary hypothesis is that both dosing regimens of Evolocumab (AMG 145) will be well tolerated and will result in greater reduction of Low Density Lipoprotein (LDL-C), than ezetimibe in hypercholesterolemic subjects unable to tolerate an effective dose of a statin.

This study is no longer open for enrollment.

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

PARADISE-MI

Prospective ARNI versus ACE inhibitor trial to  DetermIne Superiority in reducing heart failure Events after Myocardial Infarction

Sponsor: Novartis Pharmaceuticals

Purpose: The purpose of this study is to evaluate the efficacy and safety of LCZ696 titrated to a target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg twice daily, in addition to conventional post-AMI treatment, in reducing the occurrence of composite endpoint of CV death, HF hospitalization and outpatient HF (time-to-first event analysis) in post-AMI patients with evidence of LV systolic dysfunction and/or pulmonary congestion, with no known prior history of chronic HF.

Inclusion Criteria:

  1. Male or female patients ≥ 18 years of age.
  2. Diagnosis of spontaneous AMI based on the universal MI definition* with randomization to occur between 12 hours and 7 days after index event presentation. (*patients with spontaneous MI event determined to be secondary to another medical condition such as anemia, hypotension, or arrhythmia OR thought to be caused by coronary vasospasm with document normal coronary arteries are not eligible; patients with clinical presentation thought to be related to Takotsubo cardiomyopathy are also not eligible)
  3. Evidence of LV systolic dysfunction and/or pulmonary congestion requiring intravenous treatment associated with the index MI event defined as:

    • LVEF ≤40% after index MI presentation and prior to randomization and/or
    • Pulmonary congestion requiring intravenous treatment with diuretics, vasodilators, vasopressors and/or inotropes, during the index hospitalization
  4. At least one of the following 8 risk factors:

    • Age ≥ 70 years
    • eGFR <60 mL/min/1.73 m^2 based on MDRD formula at screening visit
    • Type I or II diabetes mellitus
    • Documented history of prior MI
    • Atrial fibrillation as noted by ECG, associated with index MI
    • LVEF <30% associated with index MI
    • Worst Killip class III or IV associated with index MI requiring intravenous treatment
    • STEMI without reperfusion therapy within the first 24 hours after presentation
  5. Hemodynamically stable defined as:

    • SBP ≥ 100 mmHg at randomization for patients who received ACEi/ARB during the last 24 hours prior to randomization
    • SBP ≥ 110 mmHg at randomization for patients who did not receive ACEi/ARB during the last 24 hours prior to randomization
    • No IV treatment with diuretics, vasodilators, vasopressors and/or inotropes during the 24 hours prior to randomization

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)

SPIRE 1&2

PHASE 3 MULTI CENTER, DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP EVALUATION OF THE EFFICACY, SAFETY, AND TOLERABILITY OF PF 04950615, IN REDUCING THE OCCURRENCE OF MAJOR CARDIOVASCULAR EVENTS IN HIGH AND VERY HIGH RISK SUBJECTS

Sponsor: Pfizer, Inc.

Purpose: This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization, in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C >/= 70 mg/dL (1.8 mmol/L) and < 100 mg/dL (2.6 mmol/L) or non-HDL-C >/= 100 mg /dl (2.6 mmol/L) and < 130 mg/dL (3.4 mmol/L).

This study is no longer open for enrollment.

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