Stress CMR Perfusion Imaging in the United States (SPINS) Study (NCT03192891) | Clinical Trial Compass
CompletedNot Applicable
Stress CMR Perfusion Imaging in the United States (SPINS) Study
United States2,349 participantsStarted 2016-12-01
Plain-language summary
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.
Who can participate
Age range35 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. Prior history of coronary artery bypass surgery (CABG)
✕. Acute myocardial infarction within the past 30 days prior to CMR
What they're measuring
1
Cardiovascular Mortality
Timeframe: Between 12/1/2016 to 11/30/2019, the outcome were retrospectively assessed from the date of the first index cardiac magnetic resonance imaging study (Jan-2008) to at least 4 years following the last index CMR or through study completion (Nov-2019).
2
Acute Myocardial Infarction
Timeframe: Between 12/1/2016 to 11/30/2019, the outcome were retrospectively assessed from the date of the first index cardiac magnetic resonance imaging study (Jan-2008) to at least 4 years following the last index CMR or through study completion (Nov-2019).
Trial details
NCT IDNCT03192891
SponsorSociety for Cardiovascular Magnetic Resonance
✕. any significant non-coronary cardiac conditions confirmed by medical documentation a. severe valvular heart disease, b. non-ischemic cardiomyopathy with left ventricular ejection fraction \<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)