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 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.
  • After informed consent is obtained patients are asked to complete a comprehensive questionnaire that includes questions pertinent to medical history,  medications, sleep, mood, and certain behavioral habits.
  • Blood specimens are obtained at the time of cardiac catheterization and are kept at -80ºC is for analysis of genomics, biomarker assays, and metabolomics.
  • Patients are then followed at 1 year and 5 years from the date of enrollment to identify cases of incident death, myocardial infarction, revascularization, or stroke.

EDHF

Endothelium Derived Hyperpolarizing Factor in Humans

Sponsor: Emory University

Purpose:  The purpose of this study is to elucidate the role Endothelium-Derived Hyperpolarizing Factor (EDHF) plays in dilating blood vessels and whether it differs between healthy people and those with high cholesterol. A second purpose of the study is to determine the identity of EDHF.

Inclusion Criteria:

Healthy Volunteers aged 18-60, and persons with Hypertension, Hypercholesterolemia, or Diabetes


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.

ISCHEMIA



International Study of Comparative Health Effectiveness with Medical and Invasive Approaches

Sponsor: NIH: NHLBI

Purpose: The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease. This is a multicenter randomized controlled trial with a target enrollment of ~8000 patients with at least moderate ischemia on stress imaging. Patients will be assigned at random to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and revascularization reserved for those who fail OMT.

Inclusion Criteria:

  • At least moderate ischemia on a stress imaging test with nuclear myocardial perfusion (≥10% myocardium), echo or cardiac magnetic resonance wall motion (≥3/16 segments with stress-induced severe hypokinesis or akinesis), or cardiac magnetic resonance perfusion (≥12% myocardium).
  • Participant is willing to comply with all aspects of the protocol, including adherence to medical therapy and follow-up visits
  • Age > 21 years

See the patient brochure for more information.

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.

Recruitment for this study is by invitation only.

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

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).

Inclusion Criteria:

•Must be on background lipid lowering treatment.
•Must be at high risk of a CV event.
•Must have an 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).

Exclusion Criteria:

•An LDL C < 70 mg/dL (1.8 mmol/L) or >/= 100 mg/dL (2.6 mmol/L) or non HDL-C < 100 mg/dL (2.6 mmol/L) or >/=130 mg/dL (3.4 mmol/L).
•Planned coronary (PCI or CABG) or other arterial revascularization.
•New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction < 25% by cardiac imaging.
•Chronic renal insufficiency with creatinine clearance of <30 ml/min/1.73m^2 by MDRD formula or with end state renal disease on dialysis.
•History of hemorrhagic stroke.
•Prior exposure to bococizumab or other investigational PCSK9 inhibitor.

 

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