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Delayed-Enhancement Cardiovascular Magnetic Resonance in Patients With Sarcoidosis

Sponsor
Duke University (Other)
Overall Status
Recruiting
CT.gov ID
NCT01745237
Collaborator
(none)
27,000
Enrollment
1
Location
357
Anticipated Duration (Months)
75.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study was to determine the ability of cardiac magnetic resonance (CMR) to identify cardiac involvement in patients with sarcoidosis. Patients were to undergo CMR in addition to routine clinical evaluation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In patients with sarcoidosis, cardiac death is a leading cause of mortality which may represent unrecognized cardiac involvement. Cardiovascular magnetic resonance (CMR) can detect cardiac involvement including minute amounts of myocardial damage. Therefore, the objective of this study was to determine the usefulness of CMR and compare it with standard clinical evaluation for cardiac involvement. Patients with documented extracardiac sarcoidosis or clinically suspected cardiac sarcoidosis will be enrolled.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    27000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Detection and Prognostic Significance of Myocardial Damage Visualized by Delayed-Enhancement Cardiovascular Magnetic Resonance in Patients With Sarcoidosis
    Actual Study Start Date :
    Sep 1, 2002
    Anticipated Primary Completion Date :
    Jun 1, 2032
    Anticipated Study Completion Date :
    Jun 1, 2032

    Outcome Measures

    Primary Outcome Measures

    1. cardiac mortality [> 1year]

    2. arrhythmic death [> 1year]

    3. Pulmonary mortality [> 1year]

      only in subset of patients with pulmonary sarcoidosis

    Secondary Outcome Measures

    1. all-cause mortality [> 1year]

    2. arrhythmic events [> 1year]

    3. Pulmonary Transplant [> 1 year]

    4. Cardiac Transplant [> 1 year]

    5. PPM placement/high grade AV block [> 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Biopsy proven sarcoidosis

    • Suspected cardiac sarcoidosis

    Exclusion Criteria:
    • Contraindication to MRI

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duke University Medical Center Durham North Carolina United States 27707

    Sponsors and Collaborators

    • Duke University

    Investigators

    • Principal Investigator: Raymond J Kim, MD, Duke Cardiovascular Magnetic Resonance Center, Duke University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT01745237
    Other Study ID Numbers:
    • Pro00008224
    • DCMRC-8224a
    First Posted:
    Dec 10, 2012
    Last Update Posted:
    Jul 1, 2022
    Last Verified:
    Jun 1, 2022
    Keywords provided by Duke University
    Sarcoidosis
    Cardiac Magnetic Resonance
    Additional relevant MeSH terms:
    Sarcoidosis

    Study Results

    No Results Posted as of Jul 1, 2022