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

NCT ID: NCT03192891

Last Updated: 2025-12-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2349 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-01

Study Completion Date

2019-11-30

Brief Summary

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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

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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

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Myocardial Ischemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Siemens Medical Solutions

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role collaborator

Society for Cardiovascular Magnetic Resonance

OTHER

Sponsor Role lead

Responsible Party

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Raymond Y. Kwong, MD

Principal Investigator, SPINS Study

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raymond Y Kwong, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Scripps Clinic

La Jolla, California, United States

Site Status

University of Illinois

Chicago, Illinois, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

University of Kentucky

Lexington, Kentucky, United States

Site Status

National Heart, Lung, and Blood Institute (NHLBI)

Bethesda, Maryland, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

New York-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Sharon Regional Health System

Hermitage, Pennsylvania, United States

Site Status

Houston Methodist

Houston, Texas, United States

Site Status

San Antonio Military Medical Center - Wilford Hall

San Antonio, Texas, United States

Site Status

Revere Health

Provo, Utah, United States

Site Status

Countries

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United States

References

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Ge Y, Steel K, Antiochos P, Bingham S, Abdullah S, Mikolich JR, Arai AE, Bandettini WP, Shanbhag SM, Patel AR, Farzaneh-Far A, Heitner JF, Shenoy C, Leung SW, Gonzalez JA, Shah DJ, Raman SV, Nawaz H, Ferrari VA, Schulz-Menger J, Stuber M, Simonetti OP, Kwong RY. Stress CMR in patients with obesity: insights from the Stress CMR Perfusion Imaging in the United States (SPINS) registry. Eur Heart J Cardiovasc Imaging. 2021 Apr 28;22(5):518-527. doi: 10.1093/ehjci/jeaa281.

Reference Type BACKGROUND
PMID: 33166994 (View on PubMed)

Ge Y, Antiochos P, Steel K, Bingham S, Abdullah S, Chen YY, Mikolich JR, Arai AE, Bandettini WP, Shanbhag SM, Patel AR, Farzaneh-Far A, Heitner JF, Shenoy C, Leung SW, Gonzalez JA, Shah DJ, Raman SV, Ferrari VA, Schulz-Menger J, Stuber M, Simonetti OP, Kwong RY. Prognostic Value of Stress CMR Perfusion Imaging in Patients With Reduced Left Ventricular Function. JACC Cardiovasc Imaging. 2020 Oct;13(10):2132-2145. doi: 10.1016/j.jcmg.2020.05.034. Epub 2020 Aug 5.

Reference Type BACKGROUND
PMID: 32771575 (View on PubMed)

Moschetti K, Kwong RY, Petersen SE, Lombardi M, Garot J, Atar D, Rademakers FE, Sierra-Galan LM, Mavrogeni S, Li K, Fernandes JL, Schneider S, Pinget C, Ge Y, Antiochos P, Deluigi C, Bruder O, Mahrholdt H, Schwitter J. Cost-Minimization Analysis for Cardiac Revascularization in 12 Health Care Systems Based on the EuroCMR/SPINS Registries. JACC Cardiovasc Imaging. 2022 Apr;15(4):607-625. doi: 10.1016/j.jcmg.2021.11.008. Epub 2022 Jan 12.

Reference Type BACKGROUND
PMID: 35033498 (View on PubMed)

Kwong RY, Ge Y, Steel K, Bingham S, Abdullah S, Fujikura K, Wang W, Pandya A, Chen YY, Mikolich JR, Boland S, Arai AE, Bandettini WP, Shanbhag SM, Patel AR, Narang A, Farzaneh-Far A, Romer B, Heitner JF, Ho JY, Singh J, Shenoy C, Hughes A, Leung SW, Marji M, Gonzalez JA, Mehta S, Shah DJ, Debs D, Raman SV, Guha A, Ferrari VA, Schulz-Menger J, Hachamovitch R, Stuber M, Simonetti OP. Cardiac Magnetic Resonance Stress Perfusion Imaging for Evaluation of Patients With Chest Pain. J Am Coll Cardiol. 2019 Oct 8;74(14):1741-1755. doi: 10.1016/j.jacc.2019.07.074.

Reference Type RESULT
PMID: 31582133 (View on PubMed)

Antiochos P, Ge Y, Steel K, Bingham S, Abdullah S, Mikolich JR, Arai AE, Bandettini WP, Patel AR, Farzaneh-Far A, Heitner JF, Shenoy C, Leung SW, Gonzalez JA, Shah DJ, Raman SV, Ferrari VA, Schulz-Menger J, Stuber M, Simonetti OP, Kwong RY; SPINS Study Investigators. Imaging of Clinically Unrecognized Myocardial Fibrosis in Patients With Suspected Coronary Artery Disease. J Am Coll Cardiol. 2020 Aug 25;76(8):945-957. doi: 10.1016/j.jacc.2020.06.063.

Reference Type RESULT
PMID: 32819469 (View on PubMed)

Ge Y, Pandya A, Steel K, Bingham S, Jerosch-Herold M, Chen YY, Mikolich JR, Arai AE, Bandettini WP, Patel AR, Farzaneh-Far A, Heitner JF, Shenoy C, Leung SW, Gonzalez JA, Shah DJ, Raman SV, Ferrari VA, Schulz-Menger J, Hachamovitch R, Stuber M, Simonetti OP, Kwong RY. Cost-Effectiveness Analysis of Stress Cardiovascular Magnetic Resonance Imaging for Stable Chest Pain Syndromes. JACC Cardiovasc Imaging. 2020 Jul;13(7):1505-1517. doi: 10.1016/j.jcmg.2020.02.029. Epub 2020 May 13.

Reference Type RESULT
PMID: 32417337 (View on PubMed)

Antiochos P, Ge Y, Heydari B, Steel K, Bingham S, Abdullah SM, Mikolich JR, Arai AE, Bandettini WP, Patel AR, Farzaneh-Far A, Heitner JF, Shenoy C, Leung SW, Gonzalez JA, Shah DJ, Raman SV, Ferrari VA, Schulz-Menger J, Stuber M, Simonetti OP, Kwong RY. Prognostic Value of Stress Cardiac Magnetic Resonance in Patients With Known Coronary Artery Disease. JACC Cardiovasc Imaging. 2022 Jan;15(1):60-71. doi: 10.1016/j.jcmg.2021.06.025. Epub 2021 Aug 18.

Reference Type RESULT
PMID: 34419400 (View on PubMed)

Ge Y, Antiochos P, Bernhard B, Heydari B, Steel K, Bingham S, Mikolich JR, Arai AE, Bandettini WP, Patel AR, Shanbhag SM, Farzaneh-Far A, Heitner JF, Shenoy C, Leung SW, Gonzalez JA, Shah DJ, Raman SV, Ferrari VA, Schulz-Menger J, Stuber M, Simonetti OP, Kwong RY. Stress CMR Perfusion Imaging in the Medicare-Eligible Population: Insights From the SPINS Study. JACC Cardiovasc Imaging. 2025 Jan;18(1):33-44. doi: 10.1016/j.jcmg.2024.07.029. Epub 2024 Oct 16.

Reference Type DERIVED
PMID: 39425725 (View on PubMed)

Heydari B, Ge Y, Antiochos P, Islam S, Steel K, Bingham S, Abdullah S, Mikolich JR, Arai AE, Bandettini WP, Patel AR, Shanbhag SM, Farzaneh-Far A, Heitner JF, Shenoy C, Leung SW, Gonzalez JA, Raman SV, Ferrari VA, Shah DJ, Schulz-Menger J, Stuber M, Simonetti OP, Kwong RY. Sex-Specific Stress Perfusion Cardiac Magnetic Resonance Imaging in Suspected Ischemic Heart Disease: Insights From SPINS Retrospective Registry. JACC Cardiovasc Imaging. 2023 Jun;16(6):749-764. doi: 10.1016/j.jcmg.2022.11.025. Epub 2023 Feb 8.

Reference Type DERIVED
PMID: 36764892 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SCMR_GRANT_002

Identifier Type: -

Identifier Source: org_study_id