We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Delayed-Enhancement Cardiovascular Magnetic Resonance in Patients With Sarcoidosis

This study is currently recruiting participants.
Verified January 2017 by Duke University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01745237
First Posted: December 10, 2012
Last Update Posted: January 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Duke University
  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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
Actual Study Start Date: September 2002
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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 ( Other Identifier: DUMC )
First Submitted: December 6, 2012
First Posted: December 10, 2012
Last Update Posted: January 25, 2017
Last Verified: January 2017

Keywords provided by Duke University:
Sarcoidosis
Cardiac Magnetic Resonance

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases


To Top