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

Completed

• Conditions: Myocardial Ischemia

• Registration Number: NCT03192891
• Lead Sponsor: Society for Cardiovascular Magnetic Resonance

Brief 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.

Detailed Description

Randomized multicenter studies have demonstrated the high accuracy of vasodilator stress cardiac magnetic resonance imaging (CMR) in detecting coronary stenoses and in estimating impaired flow reserve in coronary artery disease (CAD). Stress CMR has also been shown in many studies to be an effective cardiac prognosticating method for patients presenting with chest pain syndromes. The American College of Cardiology Foundation and American Heart Association have recommended stress CMR as an appropriate test for evaluation of symptomatic patients with intermediate to high pre-test probability for CAD. However, stress CMR remains an underutilized method in the United States. SPINS (Stress CMR Perfusion Imaging in the United States: A Society for Cardiovascular Resonance Registry Study) is a multicenter observational study of patients with stable chest pain syndromes designed to evaluate the long-term performance of stress CMR for cardiovascular prognosis and to investigate the cost of additional downstream cardiac testing following the index stress CMR.

Study Timeline

• Study Start: 2016-12-01
• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-06-16
• Study First Posted: 2017-06-20
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Results First Submitted: 2022-07-04
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Results First Posted: 2025-01-31
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2349

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

1. Symptoms suspicious of ischemia, or

2. 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:

   1. patient age > 50 for male, 60 for female
   2. Diabetes: by either history or medical treatment
   3. Hypertension: by either history or medical treatment
   4. Hypercholesterolemia: by either history or medical treatment
   5. family history of premature coronary disease: first degree relative at age <= 55 male and <=65 female
   6. Body mass index > 30
   7. Any medical documentation of peripheral artery disease
   8. Any history of myocardial infarction or percutaneous coronary intervention

Exclusion Criteria

1. Prior history of coronary artery bypass surgery (CABG)
2. Acute myocardial infarction within the past 30 days prior to CMR
3. 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
4. active pregnancy,
5. any competing conditions leading to an expected survival of < 2 years
6. Known inability to follow-up due to logistical reasons (e.g. patient lives in another country where follow-up is not feasible)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiovascular Mortality	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).	Patient mortality due to cardiac or vascular events
Acute Myocardial Infarction	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).	Acute myocardial infarction events that occurred after the index stress cardiac magnetic resonance imaging study, during the follow-up period

Secondary Outcome Measures

Name	Time	Method
Cardiac Hospitalizations	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).	Cardiac hospitalizations for unstable angina or worsened or new heart failure
Late Coronary Arterial Bypass Surgery	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).	Coronary arterial bypass surgery beyond 6 months after cardiac magnetic resonance imaging
Incremental Cost-Effectiveness Ratio in Dollar/Quality-Adjusted Life Year	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).	Healthcare costs spent for downstream cardiovascular testing after the cardiac magnetic resonance imaging study. The trade-offs between quality-adjusted life years and costs are evaluated using incremental cost-effectiveness analysis methods.

Trial Locations

Locations (12)

University of Illinois; 🇺🇸 Chicago, Illinois, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

National Heart, Lung, and Blood Institute (NHLBI); 🇺🇸 Bethesda, Maryland, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

New York-Presbyterian Brooklyn Methodist Hospital; 🇺🇸 Brooklyn, New York, United States

Sharon Regional Health System; 🇺🇸 Hermitage, Pennsylvania, United States

Houston Methodist; 🇺🇸 Houston, Texas, United States

San Antonio Military Medical Center - Wilford Hall; 🇺🇸 San Antonio, Texas, United States

Revere Health; 🇺🇸 Provo, Utah, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States