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Cardiac Sarcoidosis Multi-Center Prospective Cohort

Study acronym: CHASM-CS
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint removed 2 → 1 primary endpoints
See other at-risk trials from Ottawa Heart Institute Research Corporation

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary endpoint(s) modified
    • Eligibility criteria expanded, about 10 words
    • Site details revised at 2 of 14 sites
    • Publications: details revised at 2 of 2 entries
  2. Notable Primary completion date: Dec 2025 to Mar 2027
    • Study completion date: Dec 2025 to Dec 2035
    v20
  3. Minor Site contacts updated at 2 of 14 sitesv19
  4. Minor Study sites: 15 to 14v18
  5. Minor Site details revised at 1 of 15 sitesv17
Show 15 earlier versionsHide 15 earlier versions
  1. Minor Site contacts updated at 1 of 15 sitesv16
  2. Minor Study sites: 14 to 15v15
  3. Minor Study sites: 12 to 14v14
  4. Notable Enrollment target: 400 to 1500v13 Show 6 more changesShow less
    • Primary and study completion dates: Dec 2017 to Dec 2025
    • Primary endpoints: 1 to 2
    • Study sites: 10 to 12
    • Eligibility criteria expanded, about 129 words
    • Secondary endpoints: 9 to 8
    • Study description expanded, about 12 words
  5. Minor Site contacts updated at 1 of 10 sitesv12
  6. Minor Study sites: 9 to 10v11
  7. Minor Collaborators: 1 to 2v10
  8. Minor Site details revised at 1 of 9 sitesv9
  9. Minor Re-verified, no change to tracked fieldsv8
  10. Minor Study sites: 20 to 9v7
  11. Minor Re-verified, no change to tracked fieldsv6
  12. Minor Site details revised at 2 of 20 sitesv5
  13. Notable Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Dec 2016 to Dec 2017
    • Start date: Feb 2012 to Aug 2012
    • Study completion date: Feb 2017 to Dec 2017
    • Site details revised at 20 of 20 sites
  14. Minor Study sites: 19 to 20v3
  15. Notable Enrollment target: 200 to 400v2 Show 4 more changesShow less
    • Study sites: 0 to 19
    • Start date: Jan 2012 to Feb 2012
    • Eligibility criteria expanded, about 31 words
    • Study description expanded, about 54 words
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT01477359
Lead Sponsor Ottawa Heart Institute Research Corporation
Collaborators: Ontario Ministry of Health and Long Term Care, Canadian Institutes of Health Research (CIHR)
Conditions
(from sponsor)
Cardiac Sarcoidosis
Related terms Sarcoidosis
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov