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Cardiac SarcoidosisCHASM-CSNCT01477359

Cardiac Sarcoidosis Multi-Center Prospective Cohort

An observational study of Cardiac Sarcoidosis, run by Ottawa Heart Institute Research Corporation at 14 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Cardiac Sarcoidosis
How many people
1,500 participants
Where
14 sitesin 2 countries
Study dates
Aug 2012to Dec 2035
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Electrophysiology Service patients

Who may be able to join

  • To diagnose Clinically Manifest CS all following criteria must be met:
  • Positive biopsy* for Sarcoid (either EMB or extra-cardiac) AND/OR (ii) CT Chest highly suggestive of pulmonary sarcoidosis AND (iii) one or more of the following clinical features:
  • advanced conduction system disease (sustained Mobitz II AV block or third degree AV block)
  • non- sustained or sustained ventricular arrhythmia
  • ventricular dysfunction (LVEF < 50% and/or RVEF < 40%) AND (iv) No alternative explanation for clinical features AND (v) FDG-PET suggestive of active CS
  • To diagnose clinically silent CS all of the following criteria must be met
Show all 14Show fewer
  • Biopsy proven extra-cardiac sarcoidosis
  • AND/OR (ii) CT Chest highly suggestive of pulmonary sarcoidosis
  • AND (iii) CMR suggestive of cardiac sarcoidosis
  • AND (iv) Does not have criteria for clinically manifest CS ie. should not have any of following
  • advanced conduction system disease (sustained Mobitz II AV block or third degree AV block)
  • non- sustained or sustained ventricular arrhythmia
  • ventricular dysfunction (LVEF < 50% and/or RVEF < 40%)
  • Patients with negative CMR will be designated as 'extra-cardiac sarcoidosis with no evidence of CS' and followed as control

Who cannot join

  • unable or unwilling to provide informed consent
  • patients who are pregnant or lactating
  • patients with known claustrophobia
  • age < 18 years

Trial locations and contacts

14 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Janine E Ryan, BA(H), CCRP contact

613-696-7000 ext. 17077

jryan@ottawaheart.ca

David Birnie, MD contact

613-696-7269

dbirnie@ottawaheart.ca

14 sites in 2 countries

Canada13 sites, 13 recruiting

  • Libin Cardiovascular Institute of Alberta

    Calgary, Alberta, T2N 2T9

    Russell Quinn, MD

    Russell Quinn, MD

    Recruiting

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

    Tomascz Hruczkowski, MD

    Tomascz Hruczkowski, MD

    Recruiting

  • QEII Health Sciences Center

    Halifax, Nova Scotia, B3H 3A7

    Kim Anderson, MD

    Ciorsti MacIntyre, MD

    Recruiting

  • Hamilton Health Sciences Centre

    Hamilton, Ontario, L8L 2X2

    Jeff Healey, MD

    Gerard Cox, MD

    Recruiting

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

    Lorne Gula, MD

    Lorne Gula, MD

    Recruiting

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

    Lena Rivard, MD

    Lena Rivard, MD

    Recruiting

  • Centre Hospitalier de l"Universite de Montreal-Hotel Dieu

    Montreal, Quebec, H2W 1T8

    Julie Fleury, RN

    Benoit Coutu, MD

    Not yet recruiting

  • McGill University Health Centre

    Montreal, Quebec, H3G 1A4

    Fiorella Rafti

    Martin L Bernier, MD

    Recruiting

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9

    Bernice Tsang, MD

    Bernice Tsang, MD

    Recruiting

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

    Janine E Ryan, BA H, 613-696-7000 ext. 17077, jryan@ottawaheart.ca

    Tammy Knight, 613-696-7000 ext. 19080, tknight@ottawaheart.ca

    Recruiting

  • Prairie Vascular Research Inc-Regina General Hospital

    Regina, Saskatchewan, S4P 0W5

    Kendra Townsend, Ktownsend.pvri@gmail.com

    Andrea Lavoie, MD

    Recruiting

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

    Andrew Ha, MD

    Andrew Ha, MD

    Recruiting

  • St. Paul's Hospital

    Vancouver, British Columbia, V5Z 1M9

    Shanta Chakrabarti, MD

    Shanta Chakrabarti, MD

    Recruiting

Other trials in Canada

Japan1 site, 1 recruiting

  • Hokkaido University

    Sapporo, 060-8638

    Ichizo Tsujino, MD, 81-11-706-5911, itsujino@med.hokudai.ac.jp

    Ichizo Tsujino, MD

    Recruiting

Other trials in Japan

About this study

Official title: 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; 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.

Read the detailed description

Baseline assessment of Clinically Manifest CS patients consists of: history, echocardiogram, ECG, chest CT scan, FDG-PET scan, blood for biomarkers within 2 months of the PET scan, cardiac MRI and possibly a signal average ECG and biopsy (encouraged-either endomyocardial or extra-cardiac).

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. Treatment with steroids/immunosuppressants and device therapy will be at the discretion of the treating physician.

Baseline assessment of patients diagnosed with extra-cardiac sarcoidosis and being screened for CS consists of: history, echocardiogram, ECG, holter, chest CT scan, biopsy, and cardiac MRI (CMR). If the CMR is suggestive of CS the patient will be have a FDG-PET scan done and be followed as a Clinically Silent patient. They will be contacted every 2 years. If the CMR is negative the patient will be followed as a extra-cardiac sarcoidosis patient with no evidence of CS and be in the control group. They will be contacted at 5 years and at the time of study completion.

All patients will be followed until the last patient recruited has been followed for 4 years.

The occurrence of the primary and secondary outcomes will be assessed in treated and untreated patients.

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 under the direction of Dr. Mathias Friedrich (McGill University). All scans will be read in the core labs by physicians who are blinded to the clinical details of the patients.

The Biomarker core lab will be at The University of Ottawa Heart Institute under the leadership of Dr P Liu.

Keywords
Sarcoidosis
Medical subject headings
Sarcoidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01477359
Study groupRoleWhat they receive
CS screened as underlying etiology1. Patients with active Clinically Manifest CS 2. Patients diagnosed with extra-cardiac sarcoidosis and being screened for CS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Outcome for ALL Patients

    The primary outcome is a composite of cardiac death, aborted sudden cardiac death, sustained ventricular arrhythmia, heart failure hospitalization or cardiac transplantation.

    Heart failure hospitalization is defined as admission to hospital > 24 hours and received treatment for heart failure.

    Primary and secondary endpoints will be assessed at various time intervals to be decided.

    Measured: Through study completion, on average 10 years

Secondary outcomes (11)

  1. Secondary Outcomes for ALL Patients

    1. Total mortality Primary and secondary endpoints will be assessed at various time intervals to be decided.

    Measured: Through study completion, on average 10 years

  2. Secondary Outcomes for ALL Patients

    1. Individual components of primary outcome (cardiac death, aborted sudden cardiac death, sustained ventricular arrhythmia, heart failure hospitalization or cardiac transplantation) Primary and secondary endpoints will be assessed at various time intervals to be decided.

    Measured: Through study completion, on average 10 years

  3. Secondary Outcomes for Patients with Clinically Manifest Disease

    1. Change in LVEF from baseline (%) Primary and secondary endpoints will be assessed at various time intervals to be decided.

    Measured: Through study completion, on average 10 years

  4. Secondary Outcomes for Patients with Clinically Manifest Disease

    1. Change in RVEF from baseline (%) Primary and secondary endpoints will be assessed at various time intervals to be decided.

    Measured: Through study completion, on average 10 years

  5. Secondary Outcomes for Patients with Clinically Manifest Disease

    1. Change in cardiac disease activity from pre-treatment to on treatment and post-treatment cessation as assessed by FDG-PET Primary and secondary endpoints will be assessed at various time intervals to be decided.

    Measured: Through study completion, on average 10 years

  6. Secondary Outcomes for Patients with Clinically Manifest Disease

    1. Atrial fibrillation burden (from ICD and/or pacemaker diagnostics) Primary and secondary endpoints will be assessed at various time intervals to be decided.

    Measured: Through study completion, on average 10 years

  7. Secondary Outcomes for Patients with Clinically Manifest Disease

    1. Ventricular arrhythmia burden, including PVC burden (from ICD diagnostics and/or pacemaker diagnostics) Primary and secondary endpoints will be assessed at various time intervals to be decided.

    Measured: Through study completion, on average 10 years

  8. Secondary Outcomes for Patients with Clinically Manifest Disease

    1. Appropriate ICD therapy Primary and secondary endpoints will be assessed at various time intervals to be decided.

    Measured: Through study completion, on average 10 years

  9. Secondary Outcomes for Patients with Clinically Manifest Disease

    1. Percentage (%) of ventricular pacing Primary and secondary endpoints will be assessed at various time intervals to be decided.

    Measured: Through study completion, on average 10 years

  10. Secondary Outcomes for Patients with Clinically Manifest Disease

    1. AV nodal function Primary and secondary endpoints will be assessed at various time intervals to be decided.

    Measured: Through study completion, on average 10 years

  11. Secondary Outcomes for Patients with Clinically Silent Disease and Control Patients

    1. Development of Clinically Manifest CS Primary and secondary endpoints will be assessed at various time intervals to be decided.

    Measured: Through study completion, on average 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2011 (estimated)
  2. Study startAug 2012
  3. Primary completionMar 2027 (estimated)
  4. Study completionDec 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01477359
Sponsor's protocol ID
UOHI-04
Acronym
CHASM-CS
Status last verified
Jun 2026
First submitted
10 Nov 2011
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No

Publications

  • Weng W, Wiefels C, Chakrabarti S, Nery PB, Celiker-Guler E, Healey JS, Hruczkowski TW, Quinn FR, Promislow S, Medor MC, Spence S, Odabashian R, Alqarawi W, Juneau D, de Kemp R, Leung E, Beanlands R, Birnie D. Atrial Arrhythmias in Clinically Manifest Cardiac Sarcoidosis: Incidence, Burden, Predictors, and Outcomes. J Am Heart Assoc. 2020 Sep;9(17):e017086. doi: 10.1161/JAHA.120.017086. Epub 2020 Aug 20.

    PubMed 32814465

  • Martineau P, Pelletier-Galarneau M, Juneau D, Leung E, Nery PB, de Kemp R, Beanlands R, Birnie D. Imaging Cardiac Sarcoidosis With FLT-PET Compared With FDG/Perfusion-PET: A Prospective Pilot Study. JACC Cardiovasc Imaging. 2019 Nov;12(11 Pt 1):2280-2281. doi: 10.1016/j.jcmg.2019.06.020. Epub 2019 Aug 14. No abstract available.

    PubMed 31422126

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Sarcoidosis, run by Ottawa Heart Institute Research Corporation at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Canada, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Janine E Ryan, BA(H), CCRP (613-696-7000 ext. 17077, jryan@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome for ALL Patients (time frame: Through study completion, on average 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01477359, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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