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

September 10, 2019 updated by: 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

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2200

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
    • 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

Genders Eligible for Study

All

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 LVEF <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
Mortality
Time Frame: from time of study to the date 4 years following
all-cause mortality
from time of study to the date 4 years following
AMI
Time Frame: from time of study to the date 4 years following
Acute Myocardial Infarction
from time of study to the date 4 years following
Late coronary revascularization
Time Frame: from time of study to the date 4 years following
PCI or CABG beyond 60 days after CMR
from time of study to the date 4 years following

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from time of study to the date 4 years following
Cardiac event-weighted QALY
Time Frame: from time of study to the date 4 years following
from time of study to the date 4 years following

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 Healthcare

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)

March 1, 2017

Primary Completion (Actual)

March 31, 2018

Study Completion (Anticipated)

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 (Actual)

September 12, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

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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