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

December 8, 2025 updated by: Raymond Y. Kwong, MD, Society for Cardiovascular Magnetic Resonance

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

2349

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Clinic
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60612
        • University of Illinois
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
    • Maryland
      • Bethesda, Maryland, United States, 20824
        • National Heart, Lung, and Blood Institute (NHLBI)
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • New York
      • Brooklyn, New York, United States, 11215
        • New York-Presbyterian Brooklyn Methodist Hospital
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Pennsylvania
      • Hermitage, Pennsylvania, United States, 16148
        • Sharon Regional Health System
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist
      • San Antonio, Texas, United States, 78219
        • San Antonio Military Medical Center - Wilford Hall
    • Utah
      • Provo, Utah, United States, 84604
        • Revere Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients who underwent stress CMR perfusion imaging for evaluation of myocardial ischemia between 2008-2013.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular Mortality
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
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
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
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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Hospitalizations
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
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).
Late Coronary Arterial Bypass Surgery
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
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).
Incremental Cost-Effectiveness Ratio in Dollar/Quality-Adjusted Life Year
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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Society for Cardiovascular Magnetic Resonance

Collaborators

Bayer
Siemens Medical Solutions

Investigators

  • Principal Investigator: Raymond Y Kwong, MD, MPH, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

June 16, 2017

First Submitted That Met QC Criteria

June 16, 2017

First Posted (Actual)

June 20, 2017

Study Record Updates

Last Update Posted (Estimated)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCMR_GRANT_002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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