Cardiac Sarcoidosis Multi-Center Prospective Cohort
(CHASM-CS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Recent data has shown that sarcoidosis, presenting initially with cardiac manifestations (CS) of either conduction system disease or cardiomyopathy and sustained VT, is not uncommon. A Canadian physician survey found that most physicians do not investigate for CS as a possibility in these situations. Thus many patients with clinically important CS are going un-diagnosed. A study from Finland showed that missing the diagnosis of CS in these patients' leads to significant mortality and morbidity.There are no published clinical consensus guidelines on treatment of CS. Corticosteroid therapy is advocated by most experts. This is based on very modest data from small retrospective observational studies using variable definitions of clinical response. The effect of corticosteroid treatment on the clinical course of CS has not been studied in prospective studies and will be one of the aims of this project. Recent physician surveys regarding CS, in Canada and the US, found that current clinical practice varies widely. The 2008 American College of Cardiology/American Heart Association/Heart Rhythm society guidelines recommend implantation of a defibrillator (Class IIa recommendation) to prevent sudden cardiac death. The most recent Canadian device therapy guidelines do not mention CS.A multi-center collaborative approach to study CS is greatly needed." The investigators propose exactly that i.e. a multi-center prospective cohort to start to answer clinical questions. The investigators have formed the CANADIAN CARDIAC SARCOIDOSIS RESEARCH GROUP. The group includes respirologists with an interest in sarcoidosis, cardiac electrophysiologists, cardiac imaging specialists with extensive experience in imaging of sarcoidosis and biostatisticians. The research will be in two phases; a registry of current diagnostic approaches, treatment and prognosis, and a randomized clinical trial of the effect of corticosteroid treatment on the clinical course of cardiac sarcoidosis.
Who Is on the Research Team?
Pablo Nery, MD
Principal Investigator
Ottawa Heart Institute Research Corporation
Rob Beanlands, MD
Principal Investigator
Ottawa Heart Institute Research Corporation
David Birnie, MD
Principal Investigator
Ottawa Heart Institute Research Corporation
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline assessment of Clinically Manifest CS patients includes history, echocardiogram, ECG, chest CT scan, FDG-PET scan, blood for biomarkers, cardiac MRI, and possibly a signal average ECG and biopsy.
Treatment
Treatment with steroids/immunosuppressants and device therapy at the discretion of the treating physician.
Follow-up
Follow-up and clinical management of clinically manifest patients diagnosed with CS will occur at 3-6 months with a repeat FDG-PET scan and blood biomarkers. Follow-up will then be annually with an echo and ECG.
Long-term Follow-up
All patients will be followed until the last patient recruited has been followed for 4 years. Clinically Silent patients will be contacted every 2 years, and extra-cardiac sarcoidosis patients will be contacted at 5 years and at the time of study completion.
What Are the Treatments Tested in This Trial?
Interventions
- Corticosteroid Therapy
- Implantation of a defibrillator
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ottawa Heart Institute Research Corporation
Lead Sponsor
Ontario Ministry of Health and Long Term Care
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator