The Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States Study
Start Date
6/27/2025
Completion Date
3/1/2029
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.
Detailed Description
In this proposal of the Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States (SPINS2) study, the investigators seek to assess the prognostic utility of myocardial blood flow and flow reserve by quantitative stress cardiac magnetic resonance imaging compared to patients with normal quantitative perfusion indices. The investigators hypothesize that patients with abnormal myocardial blood flow and flow reserve will have higher adverse cardiac events, incremental to demographic risks and qualitative perfusion, and they should be considered for invasive workup or early institution of goal-directed medical therapies. In addition, the investigators hypothesize that quantitative perfusion by cardiac magnetic resonance imaging will characterize the myocardial extent and severity of multivessel disease and the participants' risk of adverse cardiac outcomes. Patients with chest pain syndromes and suspected ischemic heart disease who meet both inclusion and exclusion criteria will be prospectively recruited among 20 sites across the United States over the course of 1.5 years. Participants will receive standardized quantitative stress cardiac magnetic resonance imaging protocol with Gadavist (Bayer, Germany) 0.05 mmol/kg dose for each stress and rest perfusion imaging (total dose of 0.1 mmol/kg) as per Food and Drug Administration (FDA)-approved indication. All participants will receive vasodilator stress with regadenoson or adenosine depending on local site practice. A single (7-10 ml tube) whole blood sample will be collected from each patient for processing of blood biomarkers. All participants will have demographics and imaging characteristics recorded at baseline visits. Follow-up will occur via email or telephone at 3 months, 12 months, and 24 months from baseline. At each follow-up visit, medications, treatment, and adverse events will be recorded. In addition, all available electronic patient records will be reviewed in detail to capture all follow-up data which will be entered into an outline database using clearly defined data definitions. Participants will be followed for a total of 2 years from baseline cardiac magnetic resonance imaging study.
Eligibility Criteria
Age Range: 35 years to 85 years
Interventions
Quantitative Myocardial Blood Flow Evaluation
Qualitative Myocardial Blood Flow Evaluation
Gadavist
Vasodilator
Blood draw for the laboratory assessment
Conditions
Locations
University of California San Francisco
San Francisco, California 94107
United States
UofL Health - Heart Hospital
Louisville, Kentucky 40202
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
St. Francis Hospital and Heart Center
Roslyn, New York 11576
United States
Atrium Health - Sanger Heart & Vascular Institute
Charlotte, North Carolina 28204
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
The Ohio State University
Columbus, Ohio 43210
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37203
United States
Houston Methodist Hospital
Houston, Texas 77030
United States
University of Virginia
Charlottesville, Virginia 22908
United States
Virginia Commonwealth University
Richmond, Virginia 23298
United States