Clinical Trials Directory

Trials / Completed

CompletedNCT03192891

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
2,349 (actual)
Sponsor
Society for Cardiovascular Magnetic Resonance · Academic / Other
Sex
All
Age
35 Years – 85 Years
Healthy volunteers

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTStress cardiac magnetic resonance (CMR) perfusion imagingGadolinium-enhanced stress CMR perfusion imaging is a tool increasingly used for the risk assessment and diagnosis of coronary artery disease.

Timeline

Start date
2016-12-01
Primary completion
2019-11-30
Completion
2019-11-30
First posted
2017-06-20
Last updated
2025-12-30
Results posted
2025-01-31

Locations

13 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT03192891. Inclusion in this directory is not an endorsement.