Stress CMR Perfusion Imaging in the United States (SPINS) Study (SPINS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03192891 |
Recruitment Status : Unknown
Verified September 2019 by Society for Cardiovascular Magnetic Resonance.
Recruitment status was: Active, not recruiting
First Posted : June 20, 2017
Last Update Posted : September 12, 2019
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Condition or disease | Intervention/treatment |
---|---|
Myocardial Ischemia | Diagnostic Test: Stress cardiac magnetic resonance (CMR) perfusion imaging |
Study Type : | Observational |
Estimated Enrollment : | 2200 participants |
Observational Model: | Case-Only |
Time Perspective: | Retrospective |
Official Title: | Stress CMR Perfusion Imaging in the United States (SPINS) Study. A Society for Cardiovascular Magnetic Resonance (SCMR) Registry Study |
Actual Study Start Date : | March 1, 2017 |
Actual Primary Completion Date : | March 31, 2018 |
Estimated Study Completion Date : | November 30, 2019 |

- Diagnostic Test: Stress cardiac magnetic resonance (CMR) perfusion imaging
Gadolinium-enhanced stress CMR perfusion imaging is a tool increasingly used for the risk assessment and diagnosis of coronary artery disease.
- Mortality [ Time Frame: from time of study to the date 4 years following ]all-cause mortality
- AMI [ Time Frame: from time of study to the date 4 years following ]Acute Myocardial Infarction
- Late coronary revascularization [ Time Frame: from time of study to the date 4 years following ]PCI or CABG beyond 60 days after CMR
- Non-fatal cardiac events [ Time Frame: from time of study to the date 4 years following ]cardiac hospitalizations for unstable angina or heart failure, heart transplant, significant ventricular arrhythmias, and strokes
- Cardiac event-weighted QALY [ Time Frame: from time of study to the date 4 years following ]

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Ages Eligible for Study: | 35 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
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
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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 <= 55 male and <=65 female
- Body mass index > 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 LVEF <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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192891
United States, Illinois | |
University of Illinois | |
Chicago, Illinois, United States, 60612 | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, Kentucky | |
University of Kentucky | |
Lexington, Kentucky, United States, 40536 | |
United States, Maryland | |
National Heart, Lung, and Blood Institute (NHLBI) | |
Bethesda, Maryland, United States, 20824 | |
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, New York | |
New York-Presbyterian Brooklyn Methodist Hospital | |
Brooklyn, New York, United States, 11215 | |
United States, Ohio | |
Ohio State University | |
Columbus, Ohio, United States, 43210 | |
United States, Pennsylvania | |
Sharon Regional Health System | |
Hermitage, Pennsylvania, United States, 16148 | |
United States, Texas | |
Houston Methodist | |
Houston, Texas, United States, 77030 | |
San Antonio Military Medical Center - Wilford Hall | |
San Antonio, Texas, United States, 78219 | |
United States, Utah | |
Revere Health | |
Provo, Utah, United States, 84604 |
Responsible Party: | Society for Cardiovascular Magnetic Resonance |
ClinicalTrials.gov Identifier: | NCT03192891 |
Other Study ID Numbers: |
SCMR_GRANT_002 |
First Posted: | June 20, 2017 Key Record Dates |
Last Update Posted: | September 12, 2019 |
Last Verified: | September 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Myocardial Ischemia Ischemia Pathologic Processes |
Heart Diseases Cardiovascular Diseases Vascular Diseases |