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Clinical Impact of Stress CMR Perfusion Imaging (SPINS)

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ClinicalTrials.gov Identifier: NCT03192891
Recruitment Status : Active, not recruiting
First Posted : June 20, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborators:
Siemens Healthcare
Bayer
Information provided by (Responsible Party):
Society for Cardiovascular Magnetic Resonance

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.

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: The Clinical Impact of Stress CMR Perfusion Imaging in the United States (SPINS): A Global CMR Registry Substudy
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Mortality [ Time Frame: from time of study to the date 4 years following ]
    all-cause mortality

  2. AMI [ Time Frame: from time of study to the date 4 years following ]
    Acute Myocardial Infarction

  3. Late coronary revascularization [ Time Frame: from time of study to the date 4 years following ]
    PCI or CABG beyond 60 days after CMR


Secondary Outcome Measures :
  1. 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

  2. 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
Study Population
Consecutive patients who underwent stress CMR perfusion imaging for evaluation of myocardial ischemia between 2008-2013.
Criteria

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)

Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Society for Cardiovascular Magnetic Resonance
Siemens Healthcare
Bayer

Responsible Party: Society for Cardiovascular Magnetic Resonance
ClinicalTrials.gov Identifier: NCT03192891     History of Changes
Other Study ID Numbers: SCMR_GRANT_002
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
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

Additional relevant MeSH terms:
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases