Delayed-Enhancement Cardiovascular Magnetic Resonance in Patients With Sarcoidosis

December 5, 2023 updated by: Duke University

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

27000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27707
        • Recruiting
        • Duke University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Raymond J Kim, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with biopsy proven sarcoidosis or suspected cardiac sarcoidosis

Description

Inclusion Criteria:

  • Biopsy proven sarcoidosis
  • Suspected cardiac sarcoidosis

Exclusion Criteria:

  • Contraindication to MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiac mortality
Time Frame: > 1year
> 1year
arrhythmic death
Time Frame: > 1year
> 1year
Pulmonary mortality
Time Frame: > 1year
only in subset of patients with pulmonary sarcoidosis
> 1year

Secondary Outcome Measures

Outcome Measure
Time Frame
all-cause mortality
Time Frame: > 1year
> 1year
arrhythmic events
Time Frame: > 1year
> 1year
Pulmonary Transplant
Time Frame: > 1 year
> 1 year
Cardiac Transplant
Time Frame: > 1 year
> 1 year
PPM placement/high grade AV block
Time Frame: > 1 year
> 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2002

Primary Completion (Estimated)

June 1, 2032

Study Completion (Estimated)

June 1, 2032

Study Registration Dates

First Submitted

December 6, 2012

First Submitted That Met QC Criteria

December 6, 2012

First Posted (Estimated)

December 10, 2012

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00008224
  • DCMRC-8224a (Other Identifier: DUMC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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