The Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States Study
Part of paid clinical trials in San Francisco, California.
- Sponsor
- Brigham and Women's Hospital
- Study ID
- NCT06854458
- Status
- Recruiting
Conditions
- Cardiac Magnetic Resonance Imaging
- Ischemic Heart Disease (IHD)
- Myocardial Blood Flow
Eligibility Criteria
- Sex
- ALL
- Age
- 35 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Quantitative Myocardial Blood Flow Evaluation — DIAGNOSTIC_TESTThe perfusion sequence will produce on-the-fly additional quantitative perfusion maps with segmental myocardial blood flow values.
- Qualitative Myocardial Blood Flow Evaluation — DIAGNOSTIC_TESTThe perfusion sequence will not produce additional quantitative perfusion maps.
- Gadavist — DRUGParticipants will receive Gadavist 0.05 mmol/kg dose for each stress and rest perfusion imaging (total dose of 0.1 mmol/kg).
- Vasodilator — DRUGAll participants will receive vasodilator (regadenoson or adenosine depending on local site practice).
- Blood draw for the laboratory assessment — DIAGNOSTIC_TESTA single (7-10 ml tube) whole blood sample will be collected from each patient for processing of blood biomarkers.
Study Details
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.
Key Dates
- Start date
- Jun 27, 2025
- Status verified
- Feb 2026
- Primary completion
- Jan 31, 2029
- Completion
- Mar 31, 2029
Study Design
- Enrollment
- 1,000 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- DIAGNOSTIC
Arms
- Active Comparator: Standard Myocardial Blood Flow EvaluationQualitative stress cardiac magnetic resonance imaging only.
- Experimental: New Myocardial Blood Flow EvaluationQuantitative + Qualitative stress cardiac magnetic resonance imaging.
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
- Raymond Y Kwong, MD, MPH857-307-1960
- Bobby Heydari, MD, MPH
Locations (12)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94107 | Michael Salerno, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| UofL Health - Heart Hospital | Louisville | Kentucky | 40202 | Shahab Ghafghazi, MD (PRINCIPAL_INVESTIGATOR) |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Connie Tsao, MD, MPH (PRINCIPAL_INVESTIGATOR) |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | Raymond Y. Kwong, MD, MPH (PRINCIPAL_INVESTIGATOR) |
| St. Francis Hospital and Heart Center | Roslyn | New York | 11576 | Jane Cao, MD, MPH (PRINCIPAL_INVESTIGATOR) |
| Atrium Health - Sanger Heart & Vascular Institute | Charlotte | North Carolina | 28204 | Zariyat Mannan, MD (PRINCIPAL_INVESTIGATOR) |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Deborah Kwon, MD (PRINCIPAL_INVESTIGATOR) |
| The Ohio State University | Columbus | Ohio | 43210 | Matthew Tong, DO (PRINCIPAL_INVESTIGATOR) |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | Bruno Lima, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| Houston Methodist Hospital | Houston | Texas | 77030 | Faisal Nabi, MD (PRINCIPAL_INVESTIGATOR) |
| University of Virginia | Charlottesville | Virginia | 22908 | Amit Patel, MD (PRINCIPAL_INVESTIGATOR) |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | Cory Trankle, MD (PRINCIPAL_INVESTIGATOR) |
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