Actively Recruiting

Age: 18Years - 99Years
All Genders
NCT01477359

Cardiac Sarcoidosis Multi-Center Prospective Cohort

Led by Ottawa Heart Institute Research Corporation · Updated on 2024-05-08

1500

Participants Needed

14

Research Sites

695 weeks

Total Duration

On this page

Sponsors

O

Ottawa Heart Institute Research Corporation

Lead Sponsor

O

Ontario Ministry of Health and Long Term Care

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Cardiac Sarcoidosis Multi-Center Prospective Cohort

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Positive biopsy for sarcoid (either endomyocardial or extra-cardiac) and/or chest CT highly suggestive of pulmonary sarcoidosis
  • One or more clinical features: advanced conduction system disease, ventricular arrhythmia, or ventricular dysfunction (LVEF < 50% and/or RVEF < 40%)
  • No alternative explanation for clinical features
  • FDG-PET scan suggestive of active cardiac sarcoidosis
  • Biopsy proven extra-cardiac sarcoidosis and/or chest CT highly suggestive of pulmonary sarcoidosis
  • Cardiac MRI suggestive of cardiac sarcoidosis
  • For clinically silent CS, absence of advanced conduction disease, ventricular arrhythmia, or ventricular dysfunction
  • Adults aged 18 years and older
Not Eligible

You will not qualify if you...

  • Unable or unwilling to provide informed consent
  • Pregnant or lactating individuals
  • Known claustrophobia
  • Age under 18 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

Libin Cardiovascular Institute of Alberta

Calgary, Alberta, Canada, T2N 2T9

Actively Recruiting

2

University of Alberta Hospital

Edmonton, Alberta, Canada, T6G 2B7

Actively Recruiting

3

St. Paul's Hospital

Vancouver, British Columbia, Canada, V5Z 1M9

Actively Recruiting

4

QEII Health Sciences Center

Halifax, Nova Scotia, Canada, B3H 3A7

Actively Recruiting

5

Hamilton Health Sciences Centre

Hamilton, Ontario, Canada, L8L 2X2

Actively Recruiting

6

London Health Sciences Centre

London, Ontario, Canada, N6A 5A5

Actively Recruiting

7

Southlake Regional Health Centre

Newmarket, Ontario, Canada, L3Y 2P9

Actively Recruiting

8

University of Ottawa Heart Institute

Ottawa, Ontario, Canada, K1Y 4W7

Actively Recruiting

9

Toronto General Hospital

Toronto, Ontario, Canada, M5G 2C4

Actively Recruiting

10

Montreal Heart Institute

Montreal, Quebec, Canada, H1T 1C8

Actively Recruiting

11

Centre Hospitalier de l"Universite de Montreal-Hotel Dieu

Montreal, Quebec, Canada, H2W 1T8

Not Yet Recruiting

12

McGill University Health Centre

Montreal, Quebec, Canada, H3G 1A4

Actively Recruiting

13

Prairie Vascular Research Inc-Regina General Hospital

Regina, Saskatchewan, Canada, S4P 0W5

Actively Recruiting

14

Hokkaido University

Sapporo, Japan, 060-8638

Actively Recruiting

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Research Team

J

Janine E Ryan, BA(H), CCRP

CONTACT

D

David Birnie, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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