Delayed-Enhancement Cardiovascular Magnetic Resonance in Patients With Sarcoidosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01745237
First received: December 6, 2012
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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
Sarcoidosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Detection and Prognostic Significance of Myocardial Damage Visualized by Delayed-Enhancement Cardiovascular Magnetic Resonance in Patients With Sarcoidosis

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Major adverse cardiac events (MACE). [ Time Frame: greater than 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • all-cause mortality [ Time Frame: > 1year ] [ Designated as safety issue: No ]
  • cardiac mortality [ Time Frame: > 1year ] [ Designated as safety issue: No ]
  • Pulmonary mortality [ Time Frame: > 1year ] [ Designated as safety issue: No ]
    only in subset of patients with pulmonary sarcoidosis

  • Pulmonary Transplant [ Time Frame: > 1 year ] [ Designated as safety issue: No ]
  • Cardiac Transplant [ Time Frame: > 1 year ] [ Designated as safety issue: No ]
  • ICD/PPM placement [ Time Frame: > 1 year ] [ Designated as safety issue: No ]
  • Appropriate ICD therapy [ Time Frame: > 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: September 2002
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with extra cardiac sarcoidosis (confirmed by biopsy) or suspected cardiac sarcoidosis

Criteria

Inclusion Criteria:

  • Biopsy proven extra-cardiac sarcoidosis
  • Suspected cardiac sarcoidosis

Exclusion Criteria:

  • Contraindication to MRI
  Contacts and Locations
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: NCT01745237

Contacts
Contact: Han W Kim, MD 919-668-3539 kim00050@duke.edu
Contact: Raymond J. Kim, MD 919-668-3539 kim00049@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27707
Contact: Han W Kim, MD    919-668-3539    kim00050@duke.edu   
Contact: Raymond J Kim, MD    919-668-3539    kim00049@duke.edu   
Principal Investigator: Raymond J Kim, MD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Raymond J Kim, MD Duke Cardiovascular Magnetic Resonance Center, Duke University Medical Center
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01745237     History of Changes
Other Study ID Numbers: Pro00008224, DCMRC-8224a
Study First Received: December 6, 2012
Last Updated: November 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Sarcoidosis
Cardiac Magentic Resonance

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014