N/A
N=2,349
Stress CMR Perfusion Imaging in the United States (SPINS) Study
Myocardial Ischemia
Bottom Line
View on ClinicalTrials.gov: NCT03192891 ↗Enrolled (actual)
2,349
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Cardiovascular Mortality — 74 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Stress cardiac magnetic resonance (CMR) perfusion imaging (Diagnostic_test)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Society for Cardiovascular Magnetic Resonance
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiovascular Mortality |
74 | — |
| PRIMARY Acute Myocardial Infarction |
77 | — |
| SECONDARY Cardiac Hospitalizations |
124 | — |
| SECONDARY Late Coronary Arterial Bypass Surgery |
44 | — |
| SECONDARY Incremental Cost-Effectiveness Ratio in Dollar/Quality-Adjusted Life Year |
52000 | — |
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.
Eligibility Criteria
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 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 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)
Data sourced from ClinicalTrials.gov (NCT03192891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.