Clinical Impact of Stress CMR Perfusion Imaging


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This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Siemens Healthcare

Bayer

Information provided by (Responsible Party):

Society for Cardiovascular Magnetic Resonance

ClinicalTrials.gov Identifier:

NCT03192891

First received: June 16, 2017

Last updated: June 16, 2017

Last verified: June 2017

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.

Myocardial Ischemia Diagnostic Test: Stress cardiac magnetic resonance (CMR) perfusion imaging

Study Type: Observational
Study Design: 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

Primary Outcome Measures:

Secondary Outcome Measures:

  • 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

  • Alteration of diagnostic and therapeutic decision [ Time Frame: 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 ]

Estimated Enrollment: 2200
Actual Study Start Date: March 1, 2017
Estimated Study Completion Date: November 30, 2018
Estimated Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   35 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample

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

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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03192891

University of Illinois
Chicago, Illinois, United States, 60612
University of Chicago
Chicago, Illinois, United States, 60637
University of Kentucky
Lexington, Kentucky, United States, 40536
National Heart, Lung, and Blood Institute (NHLBI)
Bethesda, Maryland, United States, 20824
Brigham and Women’s Hospital
Boston, Massachusetts, United States, 02115
University of Minnesota
Minneapolis, Minnesota, United States, 55455
New York-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States, 11215
Ohio State University
Columbus, Ohio, United States, 43210
Sharon Regional Health System
Rootstown, Ohio, United States, 44272
Houston Methodist
Houston, Texas, United States, 77030
San Antonio Military Medical Center – Wilford Hall
San Antonio, Texas, United States, 78219
Revere Health
Provo, Utah, United States, 84604

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
Study First Received: June 16, 2017
Last Updated: June 16, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on June 20, 2017