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

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

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.


Condition
Cardiac Sarcoidosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Sarcoidosis Multi-Center Prospective Cohort Study

Resource links provided by NLM:


Further study details as provided by University of Ottawa Heart Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 400
Study Start Date: August 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
CS screened as underlying etiology

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Electrophysiology Service patients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01477359

Contacts
Contact: Karen E MacDonald, RN, BPE 613-798-5555 ext 17077 kmacdonald@ottawaheart.ca

Locations
Canada, Alberta
Libin Cardiovascular Institute of Alberta Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Russell Quinn, MD         
Principal Investigator: Russell Quinn, MD         
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Tomascz Hruczkowski, MD         
Principal Investigator: Tomascz Hruczkowski, MD         
Canada, British Columbia
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Shanta Chakrabarti, MD         
Principal Investigator: Shanta Chakrabarti, MD         
Canada, Ontario
Hamilton Health Sciences Centre Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Jeff Healey, MD         
Contact: Gerard Cox, MD         
Principal Investigator: Jeff Healey, MD         
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Lorne Gula, MD         
Principal Investigator: Lorne Gula, MD         
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Karen MacDonald, RN BPE    613-798-5555 ext 17077    kmacdonald@ottawaheart.ca   
Contact: Tammy Knight    613-798-5555 ext 19080    tknight@ottawaheart.ca   
Principal Investigator: Pablo Nery, MD         
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Andrew Ha, MD         
Principal Investigator: Andrew Ha, MD         
Canada, Quebec
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada, H1T 1C8
Contact: Mario Talajic, MD         
Principal Investigator: Mario Talajic, MD         
Japan
Hokkaido University Graduate School of Medicine Not yet recruiting
Sapporo, Japan
Contact: Keiichiro Yoshinaga, MD, PhD         
Principal Investigator: Keiichiro Yoshinaga, MD, PhD         
Sponsors and Collaborators
University of Ottawa Heart Institute
Ontario Ministry of Health and Long Term Care
Investigators
Principal Investigator: Pablo Nery, MD University of Ottawa Heart Institute
Principal Investigator: David Birnie, MD University of Ottawa Heart Institute
  More Information

No publications provided

Responsible Party: University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT01477359     History of Changes
Other Study ID Numbers: UOHI-04
Study First Received: November 10, 2011
Last Updated: August 20, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases

ClinicalTrials.gov processed this record on August 20, 2014