Cardiac Sarcoidosis Multi-Center Prospective Cohort

Launched by OTTAWA HEART INSTITUTE RESEARCH CORPORATION · Nov 18, 2011

Keywords

ClinConnect Summary

The Cardiac Sarcoidosis Multi-Center Prospective Cohort trial is studying a condition called cardiac sarcoidosis, which occurs when sarcoidosis affects the heart, leading to serious health issues like irregular heartbeats and heart failure. Researchers want to learn more about how common this condition is, how it’s diagnosed, and the best ways to treat it, especially the use of corticosteroids, which are a type of medication. This trial will involve multiple centers working together to collect information about patients’ experiences and outcomes.

To be eligible for the trial, participants must have a confirmed diagnosis of cardiac sarcoidosis, which can be established through specific medical tests, including biopsies or imaging scans. The study is open to adults aged 18 and older, and those selected will be monitored closely to see how their condition responds to treatment. It’s important to note that individuals who are pregnant, have certain phobias, or cannot provide consent are not eligible to participate. This research aims to improve understanding and treatment of cardiac sarcoidosis, which could help many patients who are currently not being diagnosed or treated effectively.

Gender

ALL

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