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NCT01745237 Clinical Trial

Delayed-Enhancement Cardiovascular Magnetic Resonance in Patients With Sarcoidosis

Sarcoidosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01745237
Other study ID # Pro00008224
Secondary ID DCMRC-8224a
Status Recruiting
Phase
First received
Last updated
Start date September 2002
Est. completion date June 2032

Study information
Verified date December 2023
Source Duke University
Contact Han W Kim, MD
Phone 919-668-3539
Email kim00050@duke.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 27000
Est. completion date June 2032
Est. primary completion date June 2032
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Biopsy proven sarcoidosis - Suspected cardiac sarcoidosis Exclusion Criteria: - Contraindication to MRI

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Patel MR, Cawley PJ, Heitner JF, Klem I, Parker MA, Jaroudi WA, Meine TJ, White JB, Elliott MD, Kim HW, Judd RM, Kim RJ. Detection of myocardial damage in patients with sarcoidosis. Circulation. 2009 Nov 17;120(20):1969-77. doi: 10.1161/CIRCULATIONAHA.109 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary cardiac mortality > 1year
Primary arrhythmic death > 1year
Primary Pulmonary mortality only in subset of patients with pulmonary sarcoidosis > 1year
Secondary all-cause mortality > 1year
Secondary arrhythmic events > 1year
Secondary Pulmonary Transplant > 1 year
Secondary Cardiac Transplant > 1 year
Secondary PPM placement/high grade AV block > 1 year
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