Clinical Trials

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. More information about this study

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

Principal Investigator: Arshed Quyyumi

Research Coordinator: Nisreen Haroun

Status: Enrolling

A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)

Sponsor: Eli Lilly and Company

Purpose: The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin).

Inclusion Criteria:

1. Have Lipoprotein(a) [Lp(a)] ≥175 nanomoles per liter (nmol/L).

2. Meet criteria of either 2a or 2b:

   2a: Individuals 18 years of age or older with established atherosclerotic cardiovascular disease (ASCVD) with an event or revascularization.

   2b: Individuals 55 years of age or older who are at risk for a first cardiovascular (CV) event and either: Documented coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without history of event or revascularization; known familial hypercholesteremia; or a combination of high-risk factors.

Exclusion Criteria:

1. Have had a major cardiovascular event or surgery, such as myocardial infarction (MI), stroke or coronary or peripheral revascularization, < 90 days before screening.
2. Have uncontrolled hypertension
3. Have New York Heart Association class IV heart failure.
4. Have lipoprotein apheresis within 90 days of screening, or planned lipoprotein apheresis during the study.
5. Have severe renal failure, defined as
   • Estimated glomerular rate (eGFR) <15 milliliters per minute per 1.73 meters squared (mL/min/1.73m2) at screening Visit 1, or ongoing dialysis.
6. Have a diagnosis of active nephrotic syndrome, or urine albumin-creatinine ratio (UACR) of ≥5000 mg/g at screening Visit 1.
7. Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease, or any of these laboratory results as determined by the central laboratory at screening.

Principal Investigator: Arshed A. Quyyumi, MD

Research Coordinator: Tanveer Kauser

Status: Enrollment Closed

NCT: NCT06292013

A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack (ARTEMIS)

Sponsor: Novo Nordisk

Purpose: The purpose of this study is to see if ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. 

Inclusion Criteria:

1. Age 18 years or above at the time of signing the informed consent
2. Hospitalisation for acute myocardial infarction with evidence of type 1 MI (myocardial infarction) by invasive angiography performed at site with percutaneous coronary intervention (PCI) capabilities
3. ST-segment elevation myocardial infarction (STEMI) with all the following: a) Relevant symptoms suggestive of cardiac ischaemia within 12 hours before hospitalisation or during hospitalisation, b) Electrocardiogram (ECG)-changes (in the absence of left ventricular hypertrophy or left bundle branch block): ST-segment elevation at the J point in at least two contiguous leads greater than or equal to 0.25 millivolt (mV) in men less than 40 years, greater than or equal to 0.2 mV in men greater than or equal to 40 years, or greater than or equal to 0.15 mV in women in leads V2-V3; and/or greater than or equal to 0.1 mV in all other leads OR - Non-ST-segment myocardial infarction (NSTEMI) with all the following: a) Relevant symptoms suggestive of cardiac ischaemia within 24 hours before hospitalisation or during hospitalisation, b) Rise and/or fall in cardiac troponin I or T with at least one value above the 99th percentile upper reference limit
4. Possibility for randomisation as early as possible after invasive procedure, and latest within 36 hours of hospitalisation (time 0) for STEMI, and latest within 48 hours of hospitalisation (time 0) for NSTEMI
5. Presence of at least one of the following criteria (confirmed based on the participant's medical records and/or medical history interview): a) Any prior MI b) Prior coronary revascularisation, c) Diabetes mellitus treated with glucose-lowering agent(s), d) Known chronic kidney disease (CKD) (estimated glomerular filtration rate (eGFR) greater than equal to 15 and less than 60 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2), e) Prior ischaemic stroke, f) Known carotid disease or peripheral artery disease in the lower extremities, g) Multivessel coronary artery disease (current/prior), h) For STEMI participants only: anterior MI at index AMI

Exclusion Criteria:

1. Use of fibrinolytic therapy for treatment of the current AMI (acute myocardial infarction)
2. Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV
3. Ongoing haemodynamic instability defined as any of the following: a) Killip Class III or IV, b) Sustained and/or symptomatic hypotension (systolic blood pressure less than 90 millimeters of mercury (mmHg))
4. Severe kidney impairment defined as any of the following: Chronic haemodialysis or peritoneal dialysis
5. Known alanine aminotransferase (ALT) greater than 8 x upper limit of normal (reference range) (ULN)
6. Severe hepatic disease defined as at least one of the following: a) Previously known or current hepatic encephalopathy (clinical evaluation), b) Previously known or current ascites (clinical evaluation), c) Jaundice (clinical evaluation), d) Previous oesophageal/gastric variceal bleeding, e) Known hepatic cirrhosis
7. Major cardiac surgical (including but not restricted to coronary artery bypass graft surgery [CABG]), non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days or any major surgical procedure planned at the time of randomisation or as treatment for the current AMI (CABG). Deferred (staged) percutaneous coronary intervention for a non-culprit vessel identified during the current AMI is allowed
8. Clinical evidence of, or suspicion of, active infection at the discretion of the investigator
9. Known (acute or chronic) hepatitis B or hepatitis C
10. History or evidence of untreated latent tuberculosis (TB) such as (but not limited to): a) History of a positive TB test or chest X-ray compatible with latent TB; and TB treatment initiated less than 28 days prior to randomisation, b) Participants with TB risk factors but unwilling to undergo TB treatment if confirmed positive for latent TB based on central laboratory test at baseline (visit 2)

Principal Investigator: Arshed A. Quyyumi, MD

Research Coordinator: Maheen Qazalbash

Status: Enrollment Closed

NCT: NCT06118281

A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event (AZURE-Outcomes)

Sponsor: AstraZeneca

Purpose: The purpose of this study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event.

Inclusion Criteria:

• Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening
• Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg/dL (≥ 2.6 mmol/L), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD
• Participants should receive a background lipid lowering regimen anticipated to achieve at least a ~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and/or bempedoic acid).

1. Participants must achieve a stable background lipid lowering therapy > 28 days before screening.

Exclusion Criteria:

• Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.
• Any revascularisation procedure planned within the next 3 months.
• Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.
• Calculated eGFR < 15 mL /min/1.73 m2 at screening.
• Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.
• Inadequately treated hypothyroidism defined as TSH > 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.
• Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.
• Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.
• Use of PCSK9 inhibitors: evolocumab/alirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.

Additional inclusion/exclusion criteria may apply.

Principal Investigator: Arshed A. Quyyumi, MD

Research Coordinator: Ayman Alkhoder

Status: Enrolling

NCT: NCT07000357

CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction

Sponsor: BioCardia, Inc.

Purpose: The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy system in patients with ischemic heart failure. It is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP cell therapy system to a control procedure with diagnostic catheterization.

Inclusion Criteria:

• New York Heart Association (NYHA) Class II or III
• Diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as described in the study protocol.
• Left ventricular ejection fraction >20% and <40%
• On stable evidence-based medical and device therapy for ischemic etiology heart failure per the ACC/AHA Heart Failure guidelines, for at least three (3) months prior to randomization.
• NTproBNP level of >500 pg/ml
• Autologous cell analysis score consistent with study selection assessment

Exclusion Criteria:

• Selected study criteria as defined in the study protocol indicating that patient is not an optimal candidate for cardiac catheterization or intramyocardial delivery of autologous bone marrow mononuclear cells.

Principal Investigator: Arshed Quyyumi, MD

Coordinator: Rami Najjar

Status: Enrolling

NCT: NCT06258447

Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS (dal-GenE-2)

Sponsor: DalCor Pharmaceuticals

Purpose: The goal this study is to evaluate the effect of dalcetrapib in patients recently hospitalized for ACS with the AA genetic variant. 

Inclusion:

• Subjects with the appropriate genetic background and recently hospitalized for ACS (up to 3 months following the index event), will be enrolled in this trial.
• Both male and female subjects age 45 years and over at screening visit (V1)
• AA genotype at variant gene as determined by Genotype Assay Test, conducted at a designated investigational testing site (ITS)
• Clinically stable, ie, free of ischemic symptoms at rest or with minimal exertion for at least 1 week prior to randomization
• Prior to randomization, subjects must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment.
• Randomization within 3 months of the index ACS event

Exclusion:

• Females who are pregnant (negative urine pregnancy test required for all women of child-bearing potential at Visit 2, Day 0) or breast-feeding
• Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not using at least one highly effective method of contraception.
• New York Heart Association (NYHA) Class III or IV heart failure
• Index ACS event presumed due to uncontrolled hypertension
• Systolic blood pressure (BP) >180 mmHg and/or diastolic blood pressure >110 mmHg at the time of randomization despite anti-hypertensive therapy
• Subjects with clinically apparent liver disease, eg, jaundice, cholestasis, hepatic synthetic impairment, active hepatitis or last known ALT or AST level >3 x ULN within 6 months prior to randomization (excluding index event)
• History of persistent and unexplained creatine phosphokinase (CPK) levels > 5 times the ULN as assessed within 6 months prior to randomization (excluding index event)
• Last known eGFR < 30 mL/min/1.73m2 as assessed within 6 months prior to randomization
• History of malignancy or any other significant comorbidity, the prognosis or management of which is likely to interfere with study conduct or subjects with a life expectancy of less than 3 years.
• Presence of any last known laboratory value as evaluated prior to randomization that is considered by the investigator to potentially limit the patient's successful participation in the study
• Subjects who have received any investigational drug within 1 month of randomization, or who expect to participate in any other investigational drug or device study during the conduct of this trial
• Subjects who have undergone coronary artery bypass graft (CABG) surgery between the index event and randomization

Principal Investigator: Arshed Quyyumi

Coordinator: Abdul Moiz

Status: Enrolling

NCT: NCT05918861

Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM (FOREST-HCM)

Sponsor: Cytokinetics

Purpose: The purpose of this study is to collect long-term safety and tolerability data for aficamten (CK-3773274)

Inclusion Criteria:

• Completion of a Cytokinetics trial investigating CK-3773274
• LVEF ≥55% at the Screening Visit

Exclusion Criteria:

• Has received treatment with mavacamten: (a) within 56 days prior to dosing and (b) has not received approval for participation from the Medical Monitor.
• Has participated in another investigational device or drug study or received an investigational device or drug < 1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted.

• Since completion of a previous trial of CK-3773274 has:

  • Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) <30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if heart rate (HR) <100 bpm and/or rhythm is stable >30 days
  • Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation) since the completion of a prior trial of CK-3773274.
• Had a confirmed LVEF <40% with an associated dose interruption during participation in a prior study with CK-3773274
• History of appropriate ICD shock within 30 days prior to screening

Principal Investigator: Ozlem Bilen, MD

Research Coordinator: Shaimaa Sakr

Status: Enrolling by Invitation

NCT: NCT04848506

An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)

Sponsor: Novartis Pharmaceuticals

Purpose: This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg once a month (QM) in participants with established cardiovascular disease and elevated Lp(a) who completed the parent study (CTQJ230A12301).

Inclusion Criteria

• Participants who have provided informed consent prior to initiation of any study-specific activities/procedures.
• Participants who have completed the parent study EOS visit while still on assigned investigational product.

Exclusion Criteria

• Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study.
• Participants who have a history or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator or Novartis physician (if consulted), would put the participant at risk or interfere with the study participation, including, but not restricted to conditions outlined in Table 6-3 and Table 6-5.
• Participants are receiving another investigational drug or device before the open-label treatment period.
• Participants have a known sensitivity to the study drug and are deemed as unsuited for the study by the Investigator at Screening visit.

Other protocol-defined inclusion/exclusion criteria may apply at the end.

Principal Investigator: Arshed Quyyumi

Study Coordinator: Abdul Moiz

Status: Enrollment Closed

NCT: NCT07517263

OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events

Purpose: The primary objective is to evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with elevated lipoprotein(a) (Lp[a]).

Inclusion Criteria:

• Age ≥50 years
• Lp(a)≥ 200 nmol/L during screening
• Multiple atherosclerotic cardiovascular disease risk factors, and/or evidence of atherosclerosis

Exclusion Criteria: 

• Prior acute atherothrombotic event (myocardial infarction, stroke, transient ischemic attack, acute limb ischemia)
• Prior or planned arterial revascularization
• History of major bleeding disorder

Principal Investigator: Arshed A. Quyyumi, MD

Research Coordinator: Ayman Alkhoder

Status: Enrolling

NCT: NCT07136012

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

Principal Investigator: Amit Shah, MD, MSc

Status: Enrolling

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.

Principal Investigator: Amit Shah, MD, MSc

Status: Enrolling

VictORION-INCLUSION: Evaluating INClisiran as a soLUtion to Improve LDL-C Management and cloSe Care Gaps in an Inclusive ASCVD and ASCVD Risk Equivalent populatiON

Sponsor: Novartis Pharmaceuticals

Purpose: The purpose of this study is to evaluate the effectiveness of inclisiran as an innovative therapy with the potential to help bridge care gaps in historically understudied and undertreated populations by leveraging electronic health records (EHR) in multiple US Healthcare Systems (HCS) to systematically identify those at high risk for and already diagnosed with ASCVD for more expeditious achievement of LDL-C targets.

Inclusion Criteria:

• Males and females >= 18 years of age
• Have clinical ASCVD or ASCVD risk equivalent diagnosis captured in EHR
• Serum LDL-C ≥ 70 mg/dL for participants with ASCVD, or LDL-C ≥ 100 mg/dL for ASCVD risk equivalent participants, based on last recorded LDL-C value within the preceding eighteen (18) months without a subsequent change in lipid lowering therapy.
• Willing and able to give informed consent before initiation of any study related procedures and willing to comply with all required study procedures.
• On statin therapy, or have documented statin intolerance, as determined by the treating clinician.
• From historically underrepresented populations in cardiovascular clinical research, including at least one of the following: female sex; Hispanic/Latino ethnicity; Black/African-American, Asian, or Native American race; rural dwelling based on the HRSA definition for determining rural grant eligibility.

Principal Investigator: Ijeoma Isiadinso, MD

Research Coordinator: Tanveer Kauser

Status: Enrollment Closed