Stress CMR Perfusion Imaging in the United States (SPINS) Study

Study Overview
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Brief Summary
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Numerous single-center studies have indicated gadolinium-enhanced stress CMR perfusion imaging has excellent diagnostic accuracy for coronary artery disease and negative clinical event rates, with its diagnostic accuracy exceeding nuclear scintigraphy. However, current prognostic evidence supporting clinical use of stress CMR is limited by study size, single-center settings with a predominance of academic centers, and a lack of real-world study design. Large-scale multicenter real-world evidence from a registry will provide the much needed information to guide evidence-based clinical adaptation that benefits patient care.

Official Title
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Stress CMR Perfusion Imaging in the United States (SPINS) Study. A Society for Cardiovascular Magnetic Resonance (SCMR) Registry Study

Conditions
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Myocardial Ischemia

Intervention / Treatment
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* Diagnostic Test: Stress cardiac magnetic resonance (CMR) perfusion imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all of the following at time of imaging: a) male or female at age 35-85 years, b) presence of either of the following sign/symptom that led to stress CMR imaging Symptoms suspicious of ischemia, or abnormal ECG with a suspicion of coronary artery disease c) Intermediate or high risk of significant coronary disease based on at least 2 of the following conditions: patient age > 50 for male, 60 for female Diabetes: by either history or medical treatment Hypertension: by either history or medical treatment Hypercholesterolemia: by either history or medical treatment family history of premature coronary disease: first degree relative at age <= 55 male and <=65 female Body mass index > 30 Any medical documentation of peripheral artery disease Any history of myocardial infarction or percutaneous coronary intervention Exclusion Criteria: Prior history of coronary artery bypass surgery (CABG) Acute myocardial infarction within the past 30 days prior to CMR any significant non-coronary cardiac conditions confirmed by medical documentation a. severe valvular heart disease, b. non-ischemic cardiomyopathy with LVEF <40%, c. infiltrative cardiomyopathy, d. hypertrophic cardiomyopathy, e. pericardial disease with significant constriction, or active pregnancy, any competing conditions leading to an expected survival of < 2 years Known inability to follow-up due to logistical reasons (e.g. patient lives in another country where follow-up is not feasible)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Stress cardiac magnetic resonance (CMR) perfusion imaging|Gadolinium-enhanced stress CMR perfusion imaging is a tool increasingly used for the risk assessment and diagnosis of coronary artery disease.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | all-cause mortality | from time of study to the date 4 years following | 
| AMI | Acute Myocardial Infarction | from time of study to the date 4 years following | 
| Late coronary revascularization | PCI or CABG beyond 60 days after CMR | from time of study to the date 4 years following | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-fatal cardiac events | cardiac hospitalizations for unstable angina or heart failure, heart transplant, significant ventricular arrhythmias, and strokes | from time of study to the date 4 years following | 
| Cardiac event-weighted QALY |  | from time of study to the date 4 years following |