AzTrials
AzTrials

Myocardial IschemiaSPINSNCT03192891

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

An observational study of Myocardial Ischemia, run by Society for Cardiovascular Magnetic Resonance at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 35 to 85 years
Conditions the study is for
Myocardial Ischemia
What is being tested?
Stress cardiac magnetic resonance (CMR) perfusion imaging
How many people
2,349 participants
Where
13 sitesUnited States
Study dates
1 Dec 2016to 30 Nov 2019
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 85 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites
  • National Heart, Lung, and Blood Institute (NHLBI)

    Bethesda, Maryland, 20824

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • New York-Presbyterian Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • Ohio State University

    Columbus, Ohio, 43210

  • Sharon Regional Health System

    Hermitage, Pennsylvania, 16148

  • Houston Methodist

    Houston, Texas, 77030

  • Scripps Clinic

    La Jolla, California, 92037

  • University of Kentucky

    Lexington, Kentucky, 40536

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Revere Health

    Provo, Utah, 84604

  • San Antonio Military Medical Center - Wilford Hall

    San Antonio, Texas, 78219

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Stress cardiac magnetic resonance (CMR) perfusion imaging
Medical subject headings
Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stress cardiac magnetic resonance (CMR) perfusion imagingDiagnostic test

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiovascular Mortality

    Patient mortality due to cardiac or vascular events

    Measured: 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).

  2. Acute Myocardial Infarction

    Acute myocardial infarction events that occurred after the index stress cardiac magnetic resonance imaging study, during the follow-up period

    Measured: 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)
  1. Cardiac Hospitalizations

    Cardiac hospitalizations for unstable angina or worsened or new heart failure

    Measured: 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).

  2. Late Coronary Arterial Bypass Surgery

    Coronary arterial bypass surgery beyond 6 months after cardiac magnetic resonance imaging

    Measured: 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).

  3. Incremental Cost-Effectiveness Ratio in Dollar/Quality-Adjusted Life Year

    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.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2017
  2. Study start1 Dec 2016
  3. Primary completion30 Nov 2019
  4. Study completion30 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
2,349 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03192891
Sponsor's protocol ID
SCMR_GRANT_002
Acronym
SPINS
Status last verified
Jan 2025
First submitted
16 Jun 2017
Last updated
30 Dec 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 33166994
  • 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.

    PubMed 32771575
  • 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.

    PubMed 35033498
  • 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.

    PubMed 31582133
  • 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.

    PubMed 32819469
  • 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.

    PubMed 32417337
  • 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.

    PubMed 34419400
  • 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.

    PubMed 39425725
  • 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.

    PubMed 36764892

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Ischemia, run by Society for Cardiovascular Magnetic Resonance at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03192891, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in