Multicenter stress cardiac MRI measuring heart muscle blood flow

The Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States (SPINS2) Study

This will test whether detailed stress cardiac MRI blood-flow measurements help identify heart-related causes of chest pain or shortness of breath in adults 35–85 with suspected coronary artery disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 35 Years to 85 Years
• Sex: All
• Sponsor: Brigham and Women's Hospital (Academic / other)
• Locations: 11 sites (San Francisco, California and 10 other locations)
• Trial ID: NCT06854458 on ClinicalTrials.gov

What this trial studies

This multicenter study will enroll adults with chest pain or abnormal ECGs and intermediate-to-high risk features and perform standardized quantitative stress cardiac MRI across participating U.S. centers. Each participant will undergo vasodilator stress (regadenoson or adenosine) with gadolinium-based contrast (Gadavist 0.05 mmol/kg for stress and 0.05 mmol/kg for rest) to generate quantitative myocardial blood flow and flow reserve measurements alongside routine qualitative perfusion imaging. Investigators will compare quantitative perfusion indices to qualitative imaging and clinical risk factors to see whether abnormal blood-flow measurements predict higher rates of adverse cardiac events and better characterize multivessel disease. Results will be used to determine whether quantitative perfusion should influence decisions about invasive testing or early targeted medical therapy.

Who should consider this trial

Good fit: Adults aged 35–85 who have chest pain or an anginal equivalent or an abnormal ECG with suspicion of coronary disease and intermediate or high pretest risk factors are the intended participants.

Not a fit: Patients without suspected ischemia, those with recent acute myocardial infarction within 30 days, standard contraindications to MRI or gadolinium, or very low pretest risk are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could help doctors more accurately detect reduced blood flow to the heart and better target invasive testing or preventive treatments to higher-risk patients.

How similar studies have performed: Prior smaller studies have suggested quantitative myocardial perfusion MRI can improve diagnostic accuracy, but this larger multicenter effort aims to validate those findings in a U.S. cohort.

Eligibility criteria

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

Where this trial is running

San Francisco, California and 10 other locations

• University of California San Francisco — San Francisco, California, United States (Recruiting)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
• St. Francis Hospital and Heart Center — Roslyn, New York, United States (Recruiting)
• Atrium Health - Sanger Heart & Vascular Institute — Charlotte, North Carolina, United States (Recruiting)
• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
• The Ohio State University — Columbus, Ohio, United States (Recruiting)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
• Houston Methodist Hospital — Houston, Texas, United States (Recruiting)
• University of Virginia — Charlottesville, Virginia, United States (Recruiting)
• Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Raymond Y Kwong, MD, MPH

Conditions Ischemic Heart Disease; Cardiac Magnetic Resonance Imaging; Myocardial Blood Flow; Cardiac Magnetic Resonance; Quantitative perfusion; Cardiovascular Outcomes