Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-29 @ 5:40 PM
Study NCT ID:
NCT01477359
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2011-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Sarcoidosis Multi-Center Prospective Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012507', 'term': 'Sarcoidosis'}], 'ancestors': [{'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Frozen plasma, serum and buffy coat.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2011-11-10', 'studyFirstSubmitQcDate': '2011-11-18', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinically Manifest Patients', 'timeFrame': 'On active therapy for 6 months', 'description': '"Clinically improved" if they are alive and not had a heart transplant and have not had heart failure hospitalization and no sustained VT/VF and meet one or more of following\n\n(i) No sustained VT (if presented with sustained VT) (ii) Improvement in LV function (defined as 10% decrease in LV end systolic volume or 5% absolute increase in LVEF) (iii) Resolution of conduction system disease (if presented with sustained heart block)\n\nfailure 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.'}, {'measure': 'Clinically Silent and Control Patients', 'timeFrame': '9 years', 'description': 'Cardiac death or cardiac transplantation or sustained VT/VF or sustained second or third degree AV block or development of clinical congestive heart failure (with documented LVEF \\< 50%).'}], 'secondaryOutcomes': [{'measure': 'total mortality', 'timeFrame': '6 months and 60 months'}, {'measure': 'cardiovascular mortality', 'timeFrame': '6 months and 60 months'}, {'measure': 'heart failure hospitalization', 'timeFrame': '6 months and 60 months'}, {'measure': 'change in LVEF from baseline', 'timeFrame': '6 months and 60 months'}, {'measure': 'change in disease activity as assessed by PET imaging', 'timeFrame': '6 months and 60 months', 'description': 'comparing pre-treatment to 6 month scans'}, {'measure': 'Atrial Fibrillation burden', 'timeFrame': '6 months and 60 months', 'description': 'from defibrillator diagnostics'}, {'measure': 'Ventricular arrhythmia burden', 'timeFrame': '6 months and 60 months', 'description': 'from defibrillator diagnostics'}, {'measure': '% of ventricular pacing', 'timeFrame': '6 months and 60 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sarcoidosis'], 'conditions': ['Cardiac Sarcoidosis']}, 'referencesModule': {'references': [{'pmid': '32814465', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '31422126', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThere 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.\n\nA 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.', 'detailedDescription': '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).\n\nFollow-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.\n\nBaseline 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.\n\nAll patients will be followed until the last patient recruited has been followed for 4 years.\n\nThe occurrence of the primary and secondary outcomes will be assessed in treated and untreated patients.\n\nThere 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.\n\nThe Biomarker core lab will be at The University of Ottawa Heart Institute under the leadership of Dr P Liu.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Electrophysiology Service patients', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nTo diagnose Clinically Manifest CS all following criteria must be met:\n\n(i) 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:\n\n* advanced conduction system disease (sustained Mobitz II AV block or third degree AV block)\n* non- sustained or sustained ventricular arrhythmia\n* ventricular dysfunction (LVEF \\< 50% and/or RVEF \\< 40%) AND (iv) No alternative explanation for clinical features AND (v) FDG-PET suggestive of active CS\n\nTo diagnose clinically silent CS all of the following criteria must be met\n\n(i) Biopsy proven extra-cardiac sarcoidosis\n\nAND/OR (ii) CT Chest highly suggestive of pulmonary sarcoidosis\n\nAND (iii) CMR suggestive of cardiac sarcoidosis\n\nAND (iv) Does not have criteria for clinically manifest CS ie. should not have any of following\n\n* advanced conduction system disease (sustained Mobitz II AV block or third degree AV block)\n* non- sustained or sustained ventricular arrhythmia\n* ventricular dysfunction (LVEF \\< 50% and/or RVEF \\< 40%)\n\nPatients with negative CMR will be designated as 'extra-cardiac sarcoidosis with no evidence of CS' and followed as control\n\nExclusion Criteria:\n\n* unable or unwilling to provide informed consent\n* patients who are pregnant or lactating\n* patients with known claustrophobia\n* age \\< 18 years"}, 'identificationModule': {'nctId': 'NCT01477359', 'acronym': 'CHASM-CS', 'briefTitle': 'Cardiac Sarcoidosis Multi-Center Prospective Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Heart Institute Research Corporation'}, 'officialTitle': 'Cardiac Sarcoidosis Multi-Center Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'UOHI-04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CS screened as underlying etiology', 'description': '1. Patients with active Clinically Manifest CS\n2. Patients diagnosed with extra-cardiac sarcoidosis and being screened for CS'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Russell Quinn, MD', 'role': 'CONTACT'}, {'name': 'Russell Quinn, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Libin Cardiovascular Institute of Alberta', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Tomascz Hruczkowski, MD', 'role': 'CONTACT'}, {'name': 'Tomascz Hruczkowski, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Shanta Chakrabarti, MD', 'role': 'CONTACT'}, {'name': 'Shanta Chakrabarti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'B3H 3A7', 'city': 'Halifax', 'state': 'Nova Scotia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Kim Anderson, MD', 'role': 'CONTACT'}, {'name': 'Ciorsti MacIntyre, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'QEII Health Sciences Center', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jeff Healey, MD', 'role': 'CONTACT'}, {'name': 'Gerard Cox, MD', 'role': 'CONTACT'}, {'name': 'Jeff Healey, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hamilton Health Sciences Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Lorne Gula, MD', 'role': 'CONTACT'}, {'name': 'Lorne Gula, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L3Y 2P9', 'city': 'Newmarket', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Bernice Tsang, MD', 'role': 'CONTACT'}, {'name': 'Bernice Tsang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southlake Regional Health Centre', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'K1Y 4W7', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Janine E Ryan, BA H', 'role': 'CONTACT', 'email': 'jryan@ottawaheart.ca', 'phone': '613-696-7000', 'phoneExt': '17077'}, {'name': 'Tammy Knight', 'role': 'CONTACT', 'email': 'tknight@ottawaheart.ca', 'phone': '613-696-7000', 'phoneExt': '19080'}, {'name': 'David Birnie, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Ottawa Heart Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Andrew Ha, MD', 'role': 'CONTACT'}, {'name': 'Andrew Ha, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Lena Rivard, MD', 'role': 'CONTACT'}, {'name': 'Lena Rivard, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2W 1T8', 'city': 'Montreal', 'state': 'Quebec', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Julie Fleury, RN', 'role': 'CONTACT'}, {'name': 'Benoit Coutu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de l"Universite de Montreal-Hotel Dieu', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Fiorella Rafti', 'role': 'CONTACT'}, {'name': 'Martin L Bernier, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'S4P 0W5', 'city': 'Regina', 'state': 'Saskatchewan', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Kendra Townsend', 'role': 'CONTACT', 'email': 'Ktownsend.pvri@gmail.com'}, {'name': 'Andrea Lavoie, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Prairie Vascular Research Inc-Regina General Hospital', 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}, {'zip': '060-8638', 'city': 'Sapporo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Ichizo Tsujino, MD', 'role': 'CONTACT', 'email': 'itsujino@med.hokudai.ac.jp', 'phone': '81-11-706-5911'}, {'name': 'Ichizo Tsujino, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hokkaido University', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}], 'centralContacts': [{'name': 'Janine E Ryan, BA(H), CCRP', 'role': 'CONTACT', 'email': 'jryan@ottawaheart.ca', 'phone': '613-696-7000', 'phoneExt': '17077'}, {'name': 'David Birnie, MD', 'role': 'CONTACT', 'email': 'dbirnie@ottawaheart.ca', 'phone': '613-696-7269'}], 'overallOfficials': [{'name': 'David Birnie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Heart Institute Research Corporation'}, {'name': 'Pablo Nery, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Heart Institute Research Corporation'}, {'name': 'Rob Beanlands, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Heart Institute Research Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Heart Institute Research Corporation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ontario Ministry of Health and Long Term Care', 'class': 'OTHER_GOV'}, {'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}