Routine Cardiac Screening in Sarcoidosis Patients
Completed
Conditions studied: Sarcoidosis, Cardiac Sarcoidosis, Boeck's Disease, Besnier-Boeck Disease
In brief
This protocol is an unblended randomized screening trial will have consecutive patients with no suggestion of cardiac sarcoidosis according to usual screening enroll in an enhanced screening protocol. The routine clinical care is to gather patient's history of symptoms and under go an ECG. If a patient has an abnormal results in standard screening, they typically have further evaluations as part of their routine medical care. These tests might include an echocardiogram, ambulatory ECG, and advanced cardiac imaging (MRI, PET scan as per local practice). A patient that has normal results on standard screening will be randomly assigned to enhanced screening at each center. Half the patients will be randomized to usual follow-up (annual symptom assessment and ECG) and the other half will be assigned to the enhanced screening (echocardiogram and ambulatory ECG at enrollment and at 24 months). The investigators hypothesize that screening using conventional history, physical and ECG in the general sarcoidosis population, followed by appropriate advanced imaging testing, will result in the identification of a higher percentage of ascertained cardiac sarcoidosis than has been reported historically (2-5%). The investigators hypothesize that routine use of echocardiogram with strain and ambulatory ECG will identify additional patients who will have advanced imaging abnormalities or who meet criteria for cardiac sarcoidosis. The investigators further hypothesize that re-screening patients after 24 months with repeat echocardiogram and ambulatory ECG will identify additional patients with suspicion for cardiac sarcoidosis who had no abnormalities on the standard screening tests.
Key facts
- Study ID
- NCT03902223
- Run by
- Foundation for Sarcoidosis Research
- People needed
- 1000
- Starts
- 2019-04-05
- Expected to finish
- 2024-11-01
- Last updated by the study team
- 2025-01-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of sarcoidosis as per The American Thoracic Society guidelines
- First visit to the enrolling center
- Intent to continue care at the enrolling center at least annually
You may not qualify if…
- Referred to the enrolling center to evaluate for suspected cardiac sarcoidosis.
- Pre-existing high suspicion for cardiac sarcoidosis, defined as having had cardiac MRI or cardiac PET scan, even if it was ordered by other institutions.
- Severe sarcoidosis or other disease conferring a high likelihood of death or transplant within the next year
- Unwilling or unable to undergo echocardiography and ambulatory ECG
Where it is running
- National Jewish Health — Denver, Colorado, United States
- Northwestern University Medicine — Chicago, Illinois, United States
- University of Illinois Medical Center At Chicago — Chicago, Illinois, United States
- University of Iowa Hospital — Iowa City, Iowa, United States
- Albany Medical Center — Albany, New York, United States
- University of Cincinnati Medical Center — Cincinnati, Ohio, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- Penn Medicine — Philadelphia, Pennsylvania, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- University of Washington Medical Center — Seattle, Washington, United States
- St. Antonius — Amsterdam, Nieuwegein, Netherlands
- Royal Papworth Hospital — Cambridge, United Kingdom
Full record on ClinicalTrials.gov
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