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

NCT03192891 | Completed Results

• 1 other identifier: SCMR_GRANT_002
• Study Type: observational
• Target: 2,349
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Myocardial Ischemia

Outcome Measures

Primary Outcomes (2)

• Cardiovascular Mortality

  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

  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 Outcomes (3)

• Cardiac Hospitalizations

  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

  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

  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).

Interventions

Stress cardiac magnetic resonance (CMR) perfusion imaging DIAGNOSTIC_TEST

Gadolinium-enhanced stress CMR perfusion imaging is a tool increasingly used for the risk assessment and diagnosis of coronary artery disease.

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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 left ventricular ejection fraction \<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)

Sponsors & Collaborators

• Society for Cardiovascular Magnetic Resonance: lead
• Siemens Medical Solutions: collaborator
• Bayer: collaborator

Study Sites (13)

Scripps Clinic

La Jolla, California, 92037, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

National Heart, Lung, and Blood Institute (NHLBI)

Bethesda, Maryland, 20824, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

New York-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Sharon Regional Health System

Hermitage, Pennsylvania, 16148, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

San Antonio Military Medical Center - Wilford Hall

San Antonio, Texas, 78219, United States

Location

Revere Health

Provo, Utah, 84604, United States

Location

Related Publications (9)

• 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.

  PMID: 33166994 BACKGROUND

• 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.

  PMID: 32771575 BACKGROUND

• 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.

  PMID: 35033498 BACKGROUND

• 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.

  PMID: 31582133 RESULT

• 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.

  PMID: 32819469 RESULT

• 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.

  PMID: 32417337 RESULT

• 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.

  PMID: 34419400 RESULT

• 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.

  PMID: 39425725 DERIVED

• 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.

  PMID: 36764892 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Perfusion Imaging

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Radionuclide Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Radioisotope

Results Point of Contact

• Title: Raymond Y. Kwong, MD MPH
• Organization: Brigham and Women's Hospital

rykwong@bwh.harvard.edu

8573071960

Study Officials

• Raymond Y Kwong, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, SPINS Study

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 20, 2017
• Study Start: December 1, 2016
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: December 30, 2025
• Results First Posted: January 31, 2025

Record last verified: 2025-01

Locations

US (13)