Heart Attack Research Program- Imaging Study

Myocardial Infarction Clinical Trial

— HARP  

Official title:

Heart Attack Research Program- Imaging Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02905357
• Other study ID #: 16-01104-2
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2024
• Source: NYU Langone Health
• Contact: Harmony R Reynolds, MD
• Phone: 646-501-0302
• Email: harmony.reynolds[@]nyumc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The HARP study is a multi-center, diagnostic observational study employing standardized imaging protocols in patients with MINOCA (MI with Non Obstructive Coronary Arteries) to determine the underlying diagnosis in each participant. Participants will be followed for recurrent clinical events, every 6 months, for a maximum of 10 years.

Description:

HARP is a multi-center, observational study which enrolls men and women with MI who are referred for cardiac catheterization. Eligible participants with MINOCA (defined as no stenosis of >50% in any major epicardial vessel) will undergo optical coherence tomography (OCT) at the time of diagnostic angiography and cardiac magnetic resonance imaging (CMR).

Participants will also have the option to enroll in the HARP-Platelet Sub-Study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

Inclusion Criteria:

• Acute ischemic symptoms compatible with diagnosis of MI, such as chest pain or anginal equivalent symptoms at rest or new onset exertional anginal equivalent symptoms

• Objective evidence of MI (either or both of the following):

• Elevation of troponin to above the laboratory upper limit of normal

• ST segment elevation of =1mm on 2 contiguous ECG leads

• Willing to provide informed consent and comply with all aspects of the protocol

• Age = 21 years

Exclusion Criteria:

• Stenosis =50% of any major epicardial vessel on invasive angiography, as determined by the angiographer at the time of clinically ordered cardiac catheterization

• History of known obstructive coronary artery disease at angiography, including history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)

• Recent use of vasospastic agents, such as cocaine, triptans, or ergot alkaloids (=1 month)

• Alternate explanation for troponin elevation, such as hypertensive urgency, acute exacerbation of heart failure, chronic elevation due to kidney disease, pulmonary embolism, cardiac trauma

• Coronary dissection apparent on angiography

• Excessive coronary tortuosity which, in the angiographer's opinion, increases the risks of OCT

• eGFR<45 or contraindication to additional contrast needed for OCT in the opinion of the angiographer or treating physician

• Contraindication to MRI (including but not limited to ferromagnetic implants)

• Pregnancy

• Thrombolytic therapy for STEMI (qualifying event)

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Device:
• OCT
Optical Coherence Tomography (OCT): Intracoronary imaging for amount and type of plaque as well as plaque rupture, ulceration, dissection and/or thrombosis.

Other:
• CMR
Cardiac Magnetic Resonance Imaging (CMR): MRI of the heart to identify areas of infarction (damage) and/or edema (swelling).

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary
Canada	University of Alberta	Edmonton	Alberta
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
United States	Emory University	Atlanta	Georgia
United States	Seton Heart (Ascension) Univeristy of Austin, Texas	Austin	Texas
United States	Johns Hopkins Medical Center	Baltimore	Maryland
United States	St. Luke's University Health Network	Bethlehem	Pennsylvania
United States	University of Alabama-Birmingham	Birmingham	Alabama
United States	Ohio State University Medical Center	Columbus	Ohio
United States	University of Florida Medical Center	Gainesville	Florida
United States	Dartmouth-Hitchcock	Lebanon	New Hampshire
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	NYU Winthrop	Mineola	New York
United States	Columbia University Medical Center/NYPH	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	UC San Diego Medical Center	San Diego	California
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Composite clinical endpoint: Death, unstable angina, stroke, recurrent MI, catheterizations and revascularization, other cardiac hospitalization.	components of composite will also be examined	10 years
Other	Perceived stress		1 week
Primary	Proportion of patients with MINOCA who have plaque disruption (any of the following: rupture, erosion, calcified nodule with thrombosis)		1 week
Secondary	Proportion of patients with MINOCA who have spontaneous coronary dissection.		1 week
Secondary	Proportion of patients with MINOCA who have late gadolinium enhancement and/or myocardial edema		1 week
Secondary	Correlation of the presence and location of myocardial abnormalities on CMR with presence and location of plaque disruption on OCT among women with MINOCA.		1 week
Secondary	Proportion of patients for whom an etiology can be clearly identified after combining OCT and CMR.		1 week
Secondary	Area under curve of clinical prediction model for plaque disruption on OCT in patients with MINOCA.		1 week