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NCT03902223 · ClinicalTrials.gov registry record
Routine Cardiac Screening in Sarcoidosis Patients
A clinical trial, sponsored by Foundation for Sarcoidosis Research.
- Completed
- Registry status
- 1,000
- Enrollment target
NCT03902223: Completed study, sponsored by Foundation for Sarcoidosis Research.
NCT03902223 is a clinical trial that has completed, run by Foundation for Sarcoidosis Research. The registered enrollment target is 1,000 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03902223 has completed, sponsored by Foundation for Sarcoidosis Research.
- COMPLETED
- Registry status
- 1,000 participants
- Enrollment target
Study Summary
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.
Primary Outcome
To evaluate whether second-tier screening tests (echocardiogram and ambulatory ECG) improve the rate of diagnosis of cardiac sarcoidosis beyond conventional screening methods.
Interventions
- DIAGNOSTIC_TEST Enhanced Screening Protocol for Cardiac Sarcoidosis.
- DIAGNOSTIC_TEST Routine Screening for Suspected Cardiac Sarcoidosis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2019-04-05 |
| Est. Completion | 2024-11-01 |
What the finished NCT03902223 record still lists
NCT03902223 is an observational study that tracks outcomes without assigning an intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 2 interventions - of which Enhanced Screening Protocol for Cardiac Sarcoidosis. is the first listed.
NCT03902223 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03902223 about?
NCT03902223 is a clinical study titled "Routine Cardiac Screening in Sarcoidosis Patients". 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 pati...
What is the current status of trial NCT03902223?
This trial is currently completed. The enrollment target is 1,000 participants. The study started on 2019-04-05. Estimated completion is 2024-11-01.
What interventions are being tested in trial NCT03902223?
The interventions under investigation include: Enhanced Screening Protocol for Cardiac Sarcoidosis. (DIAGNOSTIC_TEST), Routine Screening for Suspected Cardiac Sarcoidosis (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03902223?
This trial is sponsored by Foundation for Sarcoidosis Research, which has 2 total clinical trials registered on ClinicalTrials.gov.
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