Clinical Trial: Delayed-Enhancement Cardiovascular Magnetic Resonance in Patients With Sarcoidosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Detection and Prognostic Significance of Myocardial Damage Visualized by Delayed-Enhancement Cardiovascular Magnetic Resonance in Patients With Sarcoidosis

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.

Detailed Summary: 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.
Sponsor: Duke University

Current Primary Outcome: Major adverse cardiac events (MACE). [ Time Frame: greater than 1 year ]

Original Primary Outcome: Major adverse cardiac events (MACE) [ Time Frame: greater than 1 year ]

Current Secondary Outcome:

  • all-cause mortality [ Time Frame: > 1year ]
  • cardiac mortality [ Time Frame: > 1year ]
  • Pulmonary mortality [ Time Frame: > 1year ]
    only in subset of patients with pulmonary sarcoidosis
  • Pulmonary Transplant [ Time Frame: > 1 year ]
  • Cardiac Transplant [ Time Frame: > 1 year ]
  • ICD/PPM placement [ Time Frame: > 1 year ]
  • Appropriate ICD therapy [ Time Frame: > 1 year ]


Original Secondary Outcome:

  • all-cause mortality [ Time Frame: > 1year ]
  • cardiac mortality [ Time Frame: > 1year ]
  • Pulmonary mortality [ Time Frame: > 1year ]
    only in subset of patients with pulmonary sarcoidosis


Information By: Duke University

Dates:
Date Received: December 6, 2012
Date Started: September 2002
Date Completion: December 2019
Last Updated: January 24, 2017
Last Verified: January 2017