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_TEST
    The perfusion sequence will produce on-the-fly additional quantitative perfusion maps with segmental myocardial blood flow values.
  • Qualitative Myocardial Blood Flow Evaluation — DIAGNOSTIC_TEST
    The perfusion sequence will not produce additional quantitative perfusion maps.
  • Gadavist — DRUG
    Participants will receive Gadavist 0.05 mmol/kg dose for each stress and rest perfusion imaging (total dose of 0.1 mmol/kg).
  • Vasodilator — DRUG
    All participants will receive vasodilator (regadenoson or adenosine depending on local site practice).
  • Blood draw for the laboratory assessment — DIAGNOSTIC_TEST
    A 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 Evaluation
    Qualitative stress cardiac magnetic resonance imaging only.
  • Experimental: New Myocardial Blood Flow Evaluation
    Quantitative + 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

Locations (12)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94107
Katie DeSutter
559-696-1926
Michael Salerno, MD, PhD (PRINCIPAL_INVESTIGATOR)
UofL Health - Heart HospitalLouisvilleKentucky40202
Gurnoor Singh, MD
443-713-0675
Shahab Ghafghazi, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Connie Tsao, MD, MPH
(617) 667-8800
Connie Tsao, MD, MPH (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
Raymond Y Kwong, MD, MPH
857-307-1960
Raymond Y. Kwong, MD, MPH (PRINCIPAL_INVESTIGATOR)
St. Francis Hospital and Heart CenterRoslynNew York11576
Elizabeth Haag
516-562-6790
Jane Cao, MD, MPH (PRINCIPAL_INVESTIGATOR)
Atrium Health - Sanger Heart & Vascular InstituteCharlotteNorth Carolina28204
Heather Gaines
704-468-3201
Zariyat Mannan, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Danielle Burton
216-636-8883
Deborah Kwon, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43210
Debbie Scandling
000-000-0000
Matthew Tong, DO (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37203
Reynolds Cassandra
615-875-9854
Bruno Lima, MD, PhD (PRINCIPAL_INVESTIGATOR)
Houston Methodist HospitalHoustonTexas77030
Mariya Potapenko
346-238-5103
Faisal Nabi, MD (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22908
Cristiane Singulane
000-000-0000
Amit Patel, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth UniversityRichmondVirginia23298
Caleb Bridgwater
804-628-8527
Cory Trankle, MD (PRINCIPAL_INVESTIGATOR)

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