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Cardiac Sarcoidosis Multi-Center Prospective Cohort (CHASM-CS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Ottawa Heart Institute Research Corporation
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier:
NCT01477359
First received: November 10, 2011
Last updated: August 20, 2014
Last verified: August 2014

November 10, 2011
August 20, 2014
August 2012
December 2017   (final data collection date for primary outcome measure)
clinically improved [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Patients will be considered "clinically improved" if they are alive and have not had heart failure hospitalization and have not had sustained VT and one or both of: a. LV function improvement (defined as 10% decrease in LV end systolic volume) b. Resolution of conduction system disease.
Same as current
Complete list of historical versions of study NCT01477359 on ClinicalTrials.gov Archive Site
  • total mortality [ Time Frame: 6 months and 36 months ] [ Designated as safety issue: No ]
  • cardiovascular mortality [ Time Frame: 6 months and 36 months ] [ Designated as safety issue: No ]
  • heart failure hospitalization [ Time Frame: 6 months and 36 months ] [ Designated as safety issue: No ]
  • change in LVEF from baseline [ Time Frame: 6 months and 36 months ] [ Designated as safety issue: No ]
  • change in disease activity as assessed by PET imaging [ Time Frame: 6 months and 36 months ] [ Designated as safety issue: No ]
  • Atrial Fibrillation burden [ Time Frame: 6 months and 36 months ] [ Designated as safety issue: No ]
    from defibrillator diagnostics
  • Ventricular arrhythmia burden [ Time Frame: 6 months and 36 months ] [ Designated as safety issue: No ]
    from defibrillator diagnostics
  • % of ventricular pacing [ Time Frame: 6 months and 36 months ] [ Designated as safety issue: No ]
    pacemaker programming will be standardized in all patients
  • patient quality of life [ Time Frame: 6 months and 36 months ] [ Designated as safety issue: No ]
    using SF-36 questionnaire
Same as current
Not Provided
Not Provided
 
Cardiac Sarcoidosis Multi-Center Prospective Cohort
Cardiac Sarcoidosis Multi-Center Prospective Cohort Study

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 and his current application is for Phase 1 (pilot) of the prospective cohort. Twenty Canadian centers have committed to participate in this pilot study.

Baseline assessment of Group A, B & C patients consists of: history, echocardiogram, ECG, PET +/- MRI scan(s) and QOL questionnaires. Follow-up and clinical management of Group A and B patients diagnosed with CS will occur at 6 months with: echocardiogram, ECG, QOL questionnaire, device interrogation and PET scan . Further follow-up will occur at 12, 24 and 36 months with the same parameters as measured at 6 months except PET. The timeline of follow up of Group C patients will be the same as for Groups A & B however, device interrogation will only be performed on those patients with ICD implants. Based on the planned enrollment of 400 patients, it can be estimated that 38-62 patients will have CS and will have detailed follow-up. It is anticipated that a proportion of these will be treated with steroids/immunosuppressants (use of these will be up to the treating physician discretion). The occurrence of the primary and secondary outcomes will be assessed in treated and untreated patients.

It has been suggested that newer imaging modalities (PET and CMR) may have important utility in guiding therapy of CS. FDG PET and MRI maybe able to detect the early and potentially reversible stages of CS. There will be 2 imaging core labs. The PET core lab will be located at UOHI under the direction of Dr. Robert Beanlands. The CMR core lab will be located at the Montreal Heart Institute under the direction of Dr. Mathias Friedrich. All scans will be read in the core labs by physicians who are blinded to the clinical details of the patients. All scans will be read within 24 hours of receipt and reports given to the individual centers to allow clinical decision making.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Electrophysiology Service patients

Cardiac Sarcoidosis
Not Provided
CS screened as underlying etiology
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
December 2017
December 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

Group A: < 60 with unexplained, new onset, significant conduction system disease, to screen for CS as underlying etiology Group B: idiopathic non-ischemic dilated cardiomyopathy and sustained VT, to screen for CS as underlying etiology Group C: diagnosed with pulmonary/systemic sarcoidosis and being screened for CS (biopsy proven extra-cardiac sarcoidosis and abnormal ECG

Exclusion Criteria:

  • unable or unwilling to provide informed consent
  • patients who are pregnant or lactating
  • patients with known claustrophobia
  • age < 18 years
Both
18 Years and older
No
Contact: Karen E MacDonald, RN, BPE 613-798-5555 ext 17077 kmacdonald@ottawaheart.ca
Canada,   Japan
 
NCT01477359
UOHI-04
No
Ottawa Heart Institute Research Corporation
Ottawa Heart Institute Research Corporation
Ontario Ministry of Health and Long Term Care
Principal Investigator: Pablo Nery, MD Ottawa Heart Institute Research Corporation
Principal Investigator: David Birnie, MD Ottawa Heart Institute Research Corporation
Ottawa Heart Institute Research Corporation
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP