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.

BMAD Treatment: Benefits of Microcor (μCor) in Ambulatory Decompensated Heart Failure

Sponsor: Zoll

Purpose: To assess investigator engagement of μCor system data in the context of heart failure management

Inclusion Criteria:
1. Subjects hospitalized for acute decompensated heart failure and enrolled in the study within 10 days post-hospital discharge.
2. Subjects who have had an acute heart failure event requiring medical management in the previous 180 days of index hospitalization admission. This acute heart failure event admission must be at least 2 weeks apart from the event admission in
3. Subjects 21 years of age or older on the day of screening.

Exclusion Criteria:
1. Subjects who are wearing the wearable cardioverter defibrillator (WCD)
2. Subjects not expected to survive one year from enrollment from non-cardiac disease.
3. Subjects with skin allergy or sensitivity to medical adhesives.
4. Subjects anticipated to start dialysis within 90 days.
5. Subjects currently implanted with an S-ICD system.
6. Subjects who received a percutaneous coronary intervention (PCI) less than 24 hours after onset of heart failure related symptoms during index hospitalization.
7. Subjects who are unable to participate in all follow up visits.
8. Subjects participating in research other than a registry at the time of enrollment.
9. Subjects currently implanted with an LVAD.4.2.10
10. Subjects with self-reported pregnancy.
11. Subjects currently being actively managed with any device based remote HF monitoring.

Principal Investigator: Modele Ogunniyi MD, MPH 
Coordinator: Sabira Bacchus
Status: Recruiting

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

This study is no longer recruiting.

COORDINATE-Diabetes: COOrdinating CaRDIology CliNics RAndomized Trial of Interventions to improve OutcomEs

Sponsor: Duke Clinical Research Institute (DCRI)

Purpose: To test the effectiveness of an innovative, clinic-level educational intervention to improve the management of patients with T2DM and CVD.

Inclusion Criteria:
1. Age ≥ 18 years old
2. Diagnosis of Type 2 diabetes mellitus (T2DM) as reported in the patient’s medical records.
3. History of at least one of the following conditions:
a. Coronary artery disease (defined as prior MI, coronary revascularization (CABG or PCI), and/or obstructive CAD (≥50%) as documented by angiography or CTA)
b. Stroke and/or carotid artery stenosis (≥50%)
c. Peripheral Arterial disease (defined as claudication with ABI<0.9, prior peripheral revascularization, and/or amputation due to circulatory insufficiency)
4. Baseline composite score of guideline recommended therapy of <3 at baseline entry into the trial. Patients would receive a score of 1 for each of the following care elements:
• ACEi/ARB therapy
• High-intensity statin
• Most recent HbA1c<7% on metformin monotherapy
5. Ability to communicate with site staff and understand and provide written informed consent and proof of Health Insurance Portability and Accountability Act (HIPAA) authorization

Exclusion Criteria:
1.Determined to be highly unlikely to survive and/or to continue follow-up in that clinic for at least 1 year, as identified by site investigator
2.GFR<30 mL/min/1.73m
3. Baseline composite score of 3 for guideline recommended therapy (as outlined in Patient Inclusion Criterion #4) 4. Absolute contraindication to any of the 3 guideline recommended therapies (as outlined in Patient Inclusion Criterion #4)
5.Already taking SGLT2i or GLP1RA therapy at baseline

Principal Investigator: Modele Ogunniyi MD, MPH 
Research Coordinator: Senait Asier
Status: Recruiting

DELIVER: Dapagliflozin Evaluation to Improve the LIVEs of Patients with PReserved Ejection Fraction Heart Failure.

Sponsor: Astra Zeneca

Purpose: To determine whether dapagliflozin is superior to placebo, when added to standard of care, in reducing the composite of CV death and HF events (hospitalization for HF or urgent HF visit) in patients with HF and preserved systolic function

Inclusion Criteria:
1.Provision of signed informed consent prior to any study specific procedures.
2. Male or female patients age ≥40 years.
3. Documented diagnosis of symptomatic heart failure (NYHA class II-IV) at enrolment, and a medical history of typical symptoms/signs2of heart failure ≥6 weeks before enrolment with at least intermittent need for diuretic treatment.
4. Left Ventricular Ejection Fraction (LVEF) >40% and evidence of structural heart disease (i.e. left ventricular hypertrophy or left atrial enlargement3) documented by the most recent echocardiogram, and/or cardiac MR within the last 12 months prior to enrolment. For patients with prior acute cardiac events or procedures that may reduce LVEF, e.g. as defined in exclusion criterion 6, qualifying cardiac imaging assessment at least 12 weeks following the procedure/event is required.
5. NT-pro BNP ≥300 pg/ml at Visit 1 for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at Visit 1, NT-pro BNP must be ≥600 pg/mL
6. Patients may be ambulatory, or hospitalized; patients must be off intravenous heart failure therapy (including diuretics) for at least 12 hours prior to enrolment and 24 hours prior to randomisation.

Exclusion Criteria:
1. Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomization or previous intolerance to an SGLT2 inhibitor
2. Type 1 diabetes mellitus (T1D)
3. eGFR <25 mL/min/1.73 m2(CKD-EPI formula) at Visit 1
4. Systolic blood pressure (BP) <95 mmHg on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2
5. Systolic BP≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2
6. MI, unstable angina, coronary revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), ablation of atrial flutter/fibrillation, valve repair/replacement within 12 weeks prior to enrolment. Before enrolment, these patients must have their qualifying echocardiography and/or cardiac MRI examination at least 12 weeks after the event.
7. Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement.
8. Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment
9. Probable alternative or concomitant diagnoses which in the opinion of the investigator could account for the patient's HF symptoms and signs (e.g. anaemia, hypothyroidism)
10. Body mass index >50 kg/m2
11. Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD (i.e., requiring home oxygen, chronic nebulizer therapy or chronic oral steroid therapy, or hospitalizations for exacerbation of COPD requiring ventilatory assist within 12 months prior to enrolment)
12. Previous cardiac transplantation, or complex congenital heart disease. Planned cardiac resynchronisation therapy.
13. HF due to any of the following: known infiltrative cardiomyopathy (e.g. amyloid, sarcoid, lymphoma, endomyocardial fibrosis), active myocarditis, constrictive pericarditis, cardiac tamponade, known genetic hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia (ARVC/D), or uncorrected primary valvular disease
14. A life expectancy of less than 2 years due to any non-cardiovascular condition, based on investigator's clinical judgement.
15. Inability of the patient, in the opinion of the investigator, to understand and/or comply with study medications, procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
16. Active malignancy requiring treatment (with the exception of basal cell or squamous cell carcinomas of the skin).
17. Acute or chronic liver disease with severe impairment of liver function (e.g., ascites, oesophageal varices, coagulopathy)
18. Women of child-bearing potential (i.e. those who are not chemically or surgically sterilised or post-menopausal) not willing to use a medically accepted method of contraception considered reliable in the judgment of the investigator OR who have a positive pregnancy test at randomisation OR who are breast-feeding
19. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca personnel and/or personnel at the study site)
20. Previous randomisation in the present study21. Participation in another clinical study with an IP or device during the last month prior to enrolment

Principal Investigator: Modele Ogunniyi MD, MPH 
Research Coordinator: Senait Asier
Status: Recruiting

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.

EMPULSE: EMPagliflozin 10 mg compared to placebo, initiated in patients hospitalized for acUte heart faiLure (de novo or decompensated chronic HF) who have been StabilisEd

Sponsor: Boehringer Ingelheim

Purpose:
To assess whether in-hospital administration of empagliflozin results in improvement in HF-related outcomes (clinical benefit including death, heart failure events (HFE) and the burden of symptoms and physical limitations.

Inclusion Criteria:
1. Currently hospitalized for the primary diagnosis of acute heart failure (de novo or decompensated chronic HF), regardless of ejection fraction (EF). Patients with a diagnosis of heart failure, must have HF symptoms at the time of hospital admission
2. Evidence of left ventricular ejection fraction (LVEF, either reduced or preserved EF) as per local reading preferably measured during current hospitalization in the 12 months prior to randomization
3. Patients must be randomized after at least 24 hours and no later than 5 days after admission, as early as possible after stabilization while still in hospital
4. Patients must fulfil the following stabilization criteria (while in the hospital):- SBP ≥100mm Hg and no symptoms of hypotension in the preceding 6 hours, - no increase in i.v. diuretic dose for 6 hours prior to randomization,- no i.v. vasodilators including nitrates within the last 6hours prior to randomization- no i.v. inotropic drugs for 24 hours prior to randomization.
5. Elevated NT-proBNP ≥ 1600pg/mL or BNP ≥400 pg/mL according to the local lab, for patients without atrial fibrillation (AF); or elevated NT-proBNP ≥ 2400pg/mL or BNP ≥600 pg/mL for patients with AF, measured during the current hospitalization or in the 72 hours prior to hospital admission,. For patients treated with an angiotensin receptor neprilysin inhibitor (ARNI) in the previous 4 weeks prior to randomization, only NT-proBNP values should be used
6. HF episode leading to hospitalization must have been treated with a minimum dose of 40 mg of i.v. furosemide (or equivalent i.v. loop diuretic defined as 20 mg of Torsemide or 1 mg of bumetanide

Exclusion Criteria:
1. Cardiogenic shock
2. Current hospitalization for acute heart failure primarily triggered by pulmonary embolism, cerebrovascular accident, or acute myocardial infarction (AMI)
3. Current hospitalization for acute heart failure not caused primarily by intravascular volume overload;
4. Below interventions in the past 30 days prior to randomization or planned during the study:
5. Major cardiac surgery, or TAVI (Transcatheter Aortic Valve Implantation), or PCI, or Mitraclip- All other surgeries that are considered major according to investigator judgement- Implantation of cardiac resynchronisation therapy (CRT)device - cardiac mechanical support implantation- Carotid artery disease revascularization (stent or surgery)
6. Acute coronary syndrome / myocardial infarction, stroke or transient ischemic attack (TIA) in the past 90 days prior to randomization
7. Heart transplant recipient, or listed for heart transplant with expectation to receive a transplant during the course of this trial (according to investigator judgement), or planned for palliative care for HF, or currently using left ventricular assist device (LVAD) or intra-aortic balloon pump (IABP) or any other type of mechanical circulatory support, or patients on mechanical ventilation, or patients with planned inotropic support in an out-patient setting
8. Hemodynamically significant (severe) uncorrected primary cardiac valvular disease planned for surgery or intervention during the course of the study (note: secondary mitral regurgitation or tricuspid regurgitation due to dilated cardiomyopathy is not excluded unless planned for surgery or intervention during the course of the study)
9. Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2as measured during hospitalization (latest local lab measurement before randomization) or requiring dialysis
10.Type 1 Diabetes Mellitus (T1DM)• History of ketoacidosis, including diabetic ketoacidosis (DKA)

Principal Investigator: Modele Ogunniyi MD, MPH 
Research Coordinator: Senait Asier
Status: 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”

 This study is no longer recruiting.

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

This study is no longer recruiting.

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

This study is no longer recruiting.

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.