Recruiting

Cardiac Imaging

Sponsor:

Brigham and Women's Hospital

Code:

NCT06854458

Conditions

Ischemic Heart Disease (IHD)

Cardiac Magnetic Resonance Imaging

Myocardial Blood Flow

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

Interventions

Quantitative Myocardial Blood Flow Evaluation

Qualitative Myocardial Blood Flow Evaluation

Gadavist

Vasodilator

Blood draw for the laboratory assessment

Study Details

Brief summary:

This research aims to investigate whether symptoms of chest pain or shortness of breath among the study population are arising due to a heart problem, particularly any reduction of blood flow to the heart muscle from blockages in the coronary blood vessels or inflammation of the heart using cardiac magnetic resonance imaging that measures the amount of blood flow during a stress state meant to simulate vigorous exercise. At present, doctors use standard magnetic resonance imaging pictures of blood flow patterns to treat heart disease. The investigators want to study if detailed blood flow measurements, in addition to the standard blood flow pattern, could diagnose heart disease more accurately and allow more doctors to understand the severity of heart disease. Early research has demonstrated that detailed blood flow measurements may be more accurate in diagnosing heart disease in some patients, but doctors need more information to know how to use these measurements.

Conditions

Ischemic Heart Disease (IHD)

Cardiac Magnetic Resonance Imaging

Myocardial Blood Flow

Study ID

NCT06854458

Start date

Jun 27, 2025

Status verified date

Feb, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. male or female at age 35-85 years,
2. presence of either of the following sign/symptom that led to a referral to stress cardiac magnetic resonance imaging:

1. chest pain or anginal equivalent, or
2. abnormal electrocardiogram with a suspicion of coronary artery disease
3. Intermediate or high risk of significant coronary disease based on at least 1 of the following conditions:

a) patient age > 45 for male, 50 for female b) Diabetes, hypertension, or hypercholesterolemia: by either history or medical treatment c) family history of premature coronary disease: first degree relative at age <= 55 male and <=65 female d) history of smoking of > 10 packed-years e) post-menopausal state >5 years f) any chronic inflammatory conditions d) Body mass index > 30 e) Any medical documentation of coronary or peripheral artery disease

Exclusion Criteria:

1. Acute myocardial infarction within the past 30 days prior to cardiac magnetic resonance imaging
2. Confirmed diagnosis of any significant non-coronary cardiac conditions below:

1. any severe-grade valvular heart disease,
2. left ventricular ejection fraction <40% from any known non-coronary causes,
3. infiltrative cardiomyopathy,
4. hypertrophic cardiomyopathy,
5. pericardial disease with significant constriction, or
3. active pregnancy,
4. any competing conditions leading to an expected survival of < 2 years
5. contraindication to vasodilator (regadenoson or adenosine)
6. metallic device or object that poses an magnetic resonance imaging safety hazard
7. metallic device with a high likelihood of non-diagnostic cardiac magnetic resonance images

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Standard Myocardial Blood Flow Evaluation

Qualitative stress cardiac magnetic resonance imaging only.

experimental: New Myocardial Blood Flow Evaluation

Quantitative + Qualitative stress cardiac magnetic resonance imaging.

Interventions

Quantitative Myocardial Blood Flow Evaluation

The perfusion sequence will produce on-the-fly additional quantitative perfusion maps with segmental myocardial blood flow values.

Qualitative Myocardial Blood Flow Evaluation

The perfusion sequence will not produce additional quantitative perfusion maps.

Gadavist

Participants will receive Gadavist 0.05 mmol/kg dose for each stress and rest perfusion imaging (total dose of 0.1 mmol/kg).

Vasodilator

All participants will receive vasodilator (regadenoson or adenosine depending on local site practice).

Blood draw for the laboratory assessment

A single (7-10 ml tube) whole blood sample will be collected from each patient for processing of blood biomarkers.

Primary outcome measure

  • Primary composite outcome of major cardiovascular adverse events (MACE) [ Time Frame: From cardiac magnetic resonance imaging to the end of follow-up in 24 months ]

Central Contacts and Locations

Central contacts

Raymond Y Kwong, MD, MPH

857-307-1960rykwong@bwh.harvard.edu

Bobby Heydari, MD, MPH

bheydari@bwh.harvard.edu

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94107

Contacts

Principal Investigator:

Michael Salerno, MD, PhD

UofL Health - Heart Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Principal Investigator:

Shahab Ghafghazi, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Raymond Y Kwong, MD, MPH

857-307-1960rykwong@bwh.harvard.edu

Principal Investigator:

Raymond Y. Kwong, MD, MPH

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Principal Investigator:

Connie Tsao, MD, MPH

St. Francis Hospital and Heart Center

Recruiting

Roslyn, New York, United States, 11576

Contacts

Principal Investigator:

Jane Cao, MD, MPH

Atrium Health - Sanger Heart & Vascular Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Principal Investigator:

Zariyat Mannan, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Principal Investigator:

Deborah Kwon, MD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Matthew Tong, DO

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Principal Investigator:

Bruno Lima, MD, PhD

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Faisal Nabi, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Principal Investigator:

Andrew Arai, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Principal Investigator:

Amit Patel, MD

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Principal Investigator:

Cory Trankle, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Sep 1, 2026

Last verified

Feb, 2026

Keywords

  • Myocardial Blood Flow
  • Cardiac Magnetic Resonance
  • Quantitative perfusion
  • Cardiovascular Outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-09-01.