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Recruiting NCT01745237

Delayed-Enhancement Cardiovascular Magnetic Resonance in Patients With Sarcoidosis

Observational Sarcoidosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Sarcoidosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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 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.

Primary outcome measures

  • cardiac mortality [Time frame: > 1year]
  • arrhythmic death [Time frame: > 1year]
  • Pulmonary mortality [Time frame: > 1year]
Secondary outcome measures (5)
  • all-cause mortality [Time frame: > 1year]
  • arrhythmic events [Time frame: > 1year]
  • Pulmonary Transplant [Time frame: > 1 year]
  • Cardiac Transplant [Time frame: > 1 year]
  • PPM placement/high grade AV block [Time frame: > 1 year]

Eligibility criteria

Inclusion criteria

  • Biopsy proven sarcoidosis
  • Suspected cardiac sarcoidosis

Exclusion criteria

  • Contraindication to MRI

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Duke University Medical Center — Durham

Publications

  • 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.109.851352. Epub 2009 Nov 2. PMID 19884472

Identifiers

NCT: NCT01745237 · Pro00008224 · DCMRC-8224a

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗