Stress cardiac magnetic resonance (CMR) perfusion imaging
Diagnostic TestGadolinium-enhanced stress CMR perfusion imaging is a tool increasingly used for the risk assessment and diagnosis of coronary artery disease.
NCT Number: NCT03192891
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.
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Notify Me35 year–85 year
All sexes
Observational
Scripps Clinic, La Jolla, California, United States
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.
Only the study team can determine whether someone qualifies for participation.
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
Exclusion criteria
Gadolinium-enhanced stress CMR perfusion imaging is a tool increasingly used for the risk assessment and diagnosis of coronary artery disease.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Society for Cardiovascular Magnetic Resonance
Other
Stress CMR Perfusion Imaging in the United States (SPINS) Study. A Society for Cardiovascular Magnetic Resonance (SCMR) Registry Study
Acronym: SPINS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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