The Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States Study
The Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States (SPINS2) Study
Brigham and Women's Hospital
1,000 participants
Jun 27, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- male or female at age 35-85 years,
- presence of either of the following sign/symptom that led to a referral to stress cardiac magnetic resonance imaging:
- chest pain or anginal equivalent, or
- abnormal electrocardiogram with a suspicion of coronary artery disease
- 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 Criteria12
- Acute myocardial infarction within the past 30 days prior to cardiac magnetic resonance imaging
- Confirmed diagnosis of any significant non-coronary cardiac conditions below:
- any severe-grade valvular heart disease,
- left ventricular ejection fraction \<40% from any known non-coronary causes,
- infiltrative cardiomyopathy,
- hypertrophic cardiomyopathy,
- pericardial disease with significant constriction, or
- active pregnancy,
- any competing conditions leading to an expected survival of \< 2 years
- contraindication to vasodilator (regadenoson or adenosine)
- metallic device or object that poses an magnetic resonance imaging safety hazard
- metallic device with a high likelihood of non-diagnostic cardiac magnetic resonance images
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Interventions
The perfusion sequence will produce on-the-fly additional quantitative perfusion maps with segmental myocardial blood flow values.
The perfusion sequence will not produce additional quantitative perfusion maps.
Participants will receive Gadavist 0.05 mmol/kg dose for each stress and rest perfusion imaging (total dose of 0.1 mmol/kg).
All participants will receive vasodilator (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.
Locations(8)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06854458