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NCT Number: NCT01745237

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.

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Key information

Conditions

Sarcoidosis Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lymphatic Diseases Lymphoproliferative Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27707, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Biopsy proven sarcoidosis
  • Suspected cardiac sarcoidosis

Exclusion criteria

  • Contraindication to MRI

Treatment and study plan

Primary outcomes

  1. cardiac mortality

    Time frame: > 1year

  2. arrhythmic death

    Time frame: > 1year

  3. Pulmonary mortality

    Time frame: > 1year

    only in subset of patients with pulmonary sarcoidosis

Secondary outcomes

  1. all-cause mortality

    Time frame: > 1year

  2. arrhythmic events

    Time frame: > 1year

  3. Pulmonary Transplant

    Time frame: > 1 year

  4. Cardiac Transplant

    Time frame: > 1 year

  5. PPM placement/high grade AV block

    Time frame: > 1 year

Interested in participating?

Recruiting

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Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2032
Study completion
2032
First posted
Dec 10, 2012
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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