Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT01477359
Eligibility Criteria:
Inclusion Criteria:
To diagnose Clinically Manifest CS all following criteria must be met:
(i) Positive biopsy\* for Sarcoid (either EMB or extra-cardiac) AND/OR (ii) CT Chest highly suggestive of pulmonary sarcoidosis AND (iii) one or more of the following clinical features:
* advanced conduction system disease (sustained Mobitz II AV block or third degree AV block)
* non- sustained or sustained ventricular arrhythmia
* ventricular dysfunction (LVEF \< 50% and/or RVEF \< 40%) AND (iv) No alternative explanation for clinical features AND (v) FDG-PET suggestive of active CS
To diagnose clinically silent CS all of the following criteria must be met
(i) Biopsy proven extra-cardiac sarcoidosis
AND/OR (ii) CT Chest highly suggestive of pulmonary sarcoidosis
AND (iii) CMR suggestive of cardiac sarcoidosis
AND (iv) Does not have criteria for clinically manifest CS ie. should not have any of following
* advanced conduction system disease (sustained Mobitz II AV block or third degree AV block)
* non- sustained or sustained ventricular arrhythmia
* ventricular dysfunction (LVEF \< 50% and/or RVEF \< 40%)
Patients with negative CMR will be designated as 'extra-cardiac sarcoidosis with no evidence of CS' and followed as control
Exclusion Criteria:
* unable or unwilling to provide informed consent
* patients who are pregnant or lactating
* patients with known claustrophobia
* age \< 18 years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT01477359
Study Brief:
Protocol Section:
NCT01477359