Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-04 @ 8:31 PM
Study NCT ID:
NCT03593759
Status:
RECRUITING
Last Update Posted:
2024-12-03
First Post:
2018-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Sarcoidosis Randomized Trial
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, open-label, non-inferiority, randomized controlled with blinded end-point analysis.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 194}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2018-06-27', 'studyFirstSubmitQcDate': '2018-07-10', 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Summed perfusion rest score (SPRS) on FDG-PET scan', 'timeFrame': '6 months', 'description': 'Measure of myocardial scarring and fibrosis (blinded core lab analysis)'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '6 months', 'description': 'All cause deaths'}, {'measure': 'Cardiovascular hospitalizations', 'timeFrame': '6 months', 'description': 'Cardiovascular related only'}, {'measure': 'Medication related adverse events', 'timeFrame': '6 months', 'description': 'Using clinical assessment, medication side-effect and adverse event reporting'}, {'measure': 'Modified Cleveland Clinic Glucocorticoid Toxicity Score', 'timeFrame': '6 months', 'description': 'Summed score of new/worsening diabetes;new/worsening HTN; osteoporosis; change in height and weight (combined and reported as BMI in kg/m2)'}, {'measure': 'Glucocorticoid Toxicity Index', 'timeFrame': '6 months', 'description': 'Composite scoring (improvement; no significant change; worsening) compared to baseline'}, {'measure': 'Patient reported symptoms related to medication', 'timeFrame': '6 months', 'description': 'Using medication side-effect questionnaire ( symptom present, yes or no; frequency; intensity)'}, {'measure': 'Medication compliance', 'timeFrame': '6 months', 'description': '% of days where treatment was taken as prescribed'}, {'measure': 'Generic Quality of Life (SF 36)', 'timeFrame': '6 months', 'description': 'Measuring general QOL using SF-36 questionnaire'}, {'measure': 'Disease Specific Quality of Life (KSQ and SAT)', 'timeFrame': '6 months', 'description': 'Using Kings Sarcoidosis questionnaire and Sarcoidosis Assessment Tool'}, {'measure': 'BMI', 'timeFrame': '6 months', 'description': 'Weight and height combined to report BMI in kg/m2, absolute and delta compared to baseline'}, {'measure': 'Blood pressure', 'timeFrame': '6 months', 'description': 'Systolic and diastolic, absolute and delta compared to baseline'}, {'measure': 'HbA1C', 'timeFrame': '6 months', 'description': 'Absolute and delta compared to baseline'}, {'measure': 'T-score on bone density scan', 'timeFrame': '6 months', 'description': 'Absolute and delta compared to baseline'}, {'measure': 'FDG-PET and myocardial perfusion', 'timeFrame': '6 month scan', 'description': 'SPRS in mismatched segments; SUVmax, SUVmean and COI; LVEF, RVEF; whole body disease activity'}, {'measure': 'Ventricular arrhythmia burden', 'timeFrame': '6 months', 'description': 'Episodes of sustained ventricular arrhythmia or episodes requiring appropriate ICD therapy (shock or anti-tachycardia pacing)'}, {'measure': 'Complete heart block', 'timeFrame': '6 months', 'description': 'Percentage of patients who are in CHB'}, {'measure': 'LVEF and RVEF assessed on echocardiogram', 'timeFrame': '6 months', 'description': 'Ejection fraction, absolute and delta compared to baseline'}, {'measure': 'Highly sensitive Troponin I levels and BNP levels', 'timeFrame': '6 months', 'description': 'Absolute and delta compared to baseline'}, {'measure': 'CMR Endpoints', 'timeFrame': '6 months', 'description': 'Volume of delayed enhancement'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac Sarcoidosis', 'Prednisone (or Prednisolone)', 'Methotrexate'], 'conditions': ['Cardiac Sarcoidosis', 'Sarcoidosis']}, 'referencesModule': {'references': [{'pmid': '31911261', 'type': 'DERIVED', 'citation': 'Birnie D, Beanlands RSB, Nery P, Aaron SD, Culver DA, DeKemp RA, Gula L, Ha A, Healey JS, Inoue Y, Judson MA, Juneau D, Kusano K, Quinn R, Rivard L, Toma M, Varnava A, Wells G, Wickremasinghe M, Kron J. Cardiac Sarcoidosis multi-center randomized controlled trial (CHASM CS- RCT). Am Heart J. 2020 Feb;220:246-252. doi: 10.1016/j.ahj.2019.10.003. Epub 2019 Oct 20.'}]}, 'descriptionModule': {'briefSummary': 'Prospective randomized controlled trial comparing low dose Prednisone(or Prednisolone)/Methotrexate combination to standard dose Prednisone(or Prednisolone) in patients diagnosed with acute active clinically manifest cardiac sarcoidosis and not yet treated.\n\nThe Investigators hypothesize that low dose Prednisone(or Prednisolone)/Methotrexate combination will be as effective as standard dose Prednisone(or Prednisolone), and result in significantly better quality of life and less toxicity than standard dose Prednisone(or Prednisolone).', 'detailedDescription': "Subjects meeting the study inclusion/exclusion criteria will be randomized equally to receive either:\n\nEverywhere but Japan:\n\n1. Prednisone 0.5 mg kg/day for 6-months (MAX dose 30 mg per day) or\n2. Methotrexate 15-20 mg po, sc, or IM once a week for 6-months + Folic Acid OD (exact dose and directions at physician) for 6 months + Prednisone 20 mg day for 1 month, then 10 mg OD for 1 month, then 5 mg OD for one month then STOP\n\nIn Japan:\n\n1. Prednisone or prednisolone 0.5 mg/kg po (max 30mg) for one month then reduce by 5 mg per month for five months or\n2. Methotrexate 5-20mg po, sc or IM once week for 6-months +Folic Acid 2-5 mg OD for 6-months+Prednisone or prednisolone 20mg OD for 1 month then 10mg OD for 1 month then 5 mg OD one month\n\nMethotrexate will be initiated at a dose of 15 mg once a week and increased to 20 mg once a week after 4 weeks if tolerated. In case of Methotrexate-induced side-effects general guidelines will be provided, however specific management will be left to the treating physicians. Folic acid will be taken to help reduce methotrexate side-effects.\n\nPrior to randomization and study treatment all subjects will have the following baseline tests done: baseline safety blood work; FDG-PET scan with myocardial perfusion imaging; ECG; echo; and an optional bone mineral density scan. Cardiac MRI (CMR) is optional but strongly encouraged. Blood will be obtained for biomarker core-lab analysis. Biomarkers to be assayed will include highly sensitive Troponin I. Samples will be stored for future novel biomarker discovery. Quality of LIfe (QOL) questionnaires (KSQ, SAT and SF-36) will be completed prior to treatment start.\n\nAfter therapy initiation subjects will be seen at 4 weeks, 8 weeks (methotrexate arm only), and 12 weeks, with a final visit at 6 months. Safety bloodwork and assessment for medication side effects, using a medication side-effect questionnaire, will be completed at all visits. At 12 weeks QOL questionnaires will be completed. The primary endpoint will be assessed at 6-months, when FDG-PET with myocardial perfusion imaging, ECG, echo, optional bone mineral density scan, QOL questionnaires, blood for biomarkers and device interrogation will be done. CMR may be repeated. Skin, muscle strength testing and neuropsychiatric assessment will be completed at 6 months as part of the composite glucocorticoid toxicity index.\n\nAfter the 6 month visit. further management will be at the treating physician's discretion. Details of the physicians planned treatment following the 6-month PET scan will be collected.\n\nStandardized protocols for all aspects of FDG-PET scans (i.e. patient preparation, image acquisition, image processing, transfer to the core lab and analysis at core lab) will be followed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(i) Cardiac sarcoidosis presenting with one or more of the following clinical findings:\n\n* advanced conduction system disease (defined as Mobitz II AV block or third degree AV block)\n* significant sinus node dysfunction (defined as average HR less than 40bpm when awake and/or sustained atrial arrhythmias)\n* non- sustained or sustained ventricular arrhythmia\n* left ventricular dysfunction (LVEF \\< 50%)\n* right ventricular dysfunction (RVEF \\< 40%)\n\nAND\n\n(ii) No alternative explanation for clinical features\n\nAND\n\n(iii) Nuclear Imaging within six-months of enrollment consisting of FDG-PET scan with FDG uptake suggestive of active CS and myocardial perfusion imaging\n\nAND ONE OR BOTH OF FOLLOWING\n\n(iv) Positive biopsy for Sarcoid (either EMB or extra-cardiac)\n\n(v) CT Chest showing features consistent with pulmonary sarcoidosis and/or mediastinal and/or hilar lymphadenopathy\n\nExclusion Criteria:\n\n1. Current or recent (within two months) non-topical treatment for sarcoidosis\n2. Current Oral/IV treatment of duration greater than 5 days\n3. Currently taking Methotrexate or Prednisone for another health condition\n4. Intolerance or contra-indication to Methotrexate or Prednisone\n5. Patient does not meet all of the above listed inclusion criteria\n6. Patient is unable or unwilling to provide informed consent\n7. Patient is included in another randomized clinical trial\n8. Patient has a contraindication to PET imaging or is unlikely to tolerate due to severe claustrophobia\n9. Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrollment)\n10. Breastfeeding\n11. Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study\n12. Patients for whom the investigator believes that the trial is not in the interest of the patient'}, 'identificationModule': {'nctId': 'NCT03593759', 'acronym': 'CHASM-CS-RCT', 'briefTitle': 'Cardiac Sarcoidosis Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Heart Institute Research Corporation'}, 'officialTitle': 'Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'UOttawaHI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Prednisone (or Prednisolone)', 'description': '\\[Dose everywhere except Japan\\] Prednisone 0.5 mg kg/day for 6 months (max dose 30 mg)\n\n\\[Dose in Japan\\] Prednisone or prednisolone 0.5 mg/kg po (max 30mg) for one month then reduce by 5 mg per month for five months', 'interventionNames': ['Drug: Prednisone or Prednisolone']}, {'type': 'EXPERIMENTAL', 'label': 'Methotrexate', 'description': '\\[Dose everywhere except Japan\\] Methotrexate 15-20 mg orally, sc, or IM once a week for 6 months + Prednisone 20 mg po daily for one month then 10 mg po daily for one month then 5 mg po daily for one month and then stop. Also Folic Acid OD (exact dose and directions at physicians discretion) for 6 months.\n\n\\[Dose in Japan\\] Methotrexate 5-20mg mg orally, sc, or IM once a week for 6 months+ Prednisone or Prednisolone 20mg OD for 1 month then 10mg OD for 1 month then 5 mg OD one month. Also Folic Acid 2 mg po daily for 6 months.', 'interventionNames': ['Drug: Prednisone or Prednisolone', 'Drug: Methotrexate']}], 'interventions': [{'name': 'Prednisone or Prednisolone', 'type': 'DRUG', 'description': 'Oral prednisone/prednisolone tablet', 'armGroupLabels': ['Methotrexate', 'Prednisone (or Prednisolone)']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Oral, subcutaneous, or intramuscular methotrexate', 'armGroupLabels': ['Methotrexate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Edward Miller, MD', 'role': 'CONTACT', 'email': 'edward.miller@yale.edu', 'phone': '203-737-8871'}, {'name': 'Edward Miller, MD', 'role': 'CONTACT'}], 'facility': 'Yale-New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mili Mehta, MD', 'role': 'CONTACT'}, {'name': 'Amanda Vest, MD', 'role': 'CONTACT'}], 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109-5853', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Todd Koelling, MD', 'role': 'CONTACT', 'email': 'tkoellin@med.umich.edu', 'phone': '734-936-5265'}, {'name': 'Todd Koelling, MD', 'role': 'CONTACT'}], 'facility': 'University of Michigan-Michigan Medicine Cardiovascular Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55455', 'city': 'Minneota', 'state': 'Minnesota', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'C Shenoy, MD', 'role': 'CONTACT'}], 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.55885, 'lon': -95.98559}}, {'zip': '10467', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yogita Rochlani, MD', 'role': 'CONTACT', 'email': 'yrochlani@montefiore.org'}, {'name': 'Yogita Rochlani, MD', 'role': 'CONTACT'}], 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Steven Kalbfleisch, MD', 'role': 'CONTACT', 'email': 'steven.kalbfleisch@osumc.edu'}, {'name': 'Steven Kalbfleisch, MD', 'role': 'CONTACT'}], 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Indu Poornima, MD', 'role': 'CONTACT', 'email': 'indu.poornima@ahn.org'}, {'name': 'Indu Poornima, MD', 'role': 'CONTACT'}], 'facility': 'Allegheny General Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Line Kemeyou, MD', 'role': 'CONTACT', 'email': 'line.kemeyou@hsc.utah.edu'}, {'name': 'Line Kemeyou, MD', 'role': 'CONTACT'}], 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23298-0053', 'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jordana Kron, MD', 'role': 'CONTACT', 'email': 'jordana.kron@vcuhealth.org', 'phone': '804-828-7565'}, {'name': 'Jordana Kron, MD', 'role': 'CONTACT'}], 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Russell Quinn, MD', 'role': 'CONTACT', 'email': 'frquinn@ucalgary.ca', 'phone': '403-220-5500'}, {'name': 'Russell Quinn, MD', 'role': 'CONTACT'}], 'facility': 'Libin Cardiovascular Institute of Alberta', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Mustafa Toma, MD', 'role': 'CONTACT', 'email': 'MToma@providencehealth.bc.ca', 'phone': '604 806 9986'}, {'name': 'Mustafa Toma, MD', 'role': 'CONTACT'}], 'facility': "St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'A1B 3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Stephen Duffett, MD', 'role': 'CONTACT', 'email': 'sduffett@mun.ca', 'phone': '709-777-6917'}, {'name': 'Stephen Duffett, MD', 'role': 'CONTACT'}], 'facility': 'Eastern Health Health Sciences Centre', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'B3H 3A7', 'city': 'Halifax', 'state': 'Nova Scotia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Doug Hayami, MD', 'role': 'CONTACT', 'email': 'doug.hayami@nshealth.ca'}, {'name': 'Doug Hayami, MD', 'role': 'CONTACT'}], 'facility': 'QE II Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8N 4A6', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Nathan Hambly, MD', 'role': 'CONTACT', 'email': 'nathan.hambly@medportal.ca', 'phone': '905-521-6183'}, {'name': 'Nathan Hambly, MD', 'role': 'CONTACT'}], 'facility': "St. Joseph's Healthcare Centre", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 4A5', 'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Nikolaos Tzemos, MD', 'role': 'CONTACT', 'email': 'Niko.Tzemos@lhsc.on.ca', 'phone': '519-663-3038'}, {'name': 'Nikolaos Tzemos, MD', 'role': 'CONTACT'}], 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K1Y 4W7', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'David H Birnie, MD', 'role': 'CONTACT', 'email': 'dbirnie@ottawaheart.ca', 'phone': '613-696-7269'}, {'name': 'David Birnie, MD', 'role': 'CONTACT'}], 'facility': 'University of Ottawa Heart Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Genevieve Giraldeau, MD', 'role': 'CONTACT', 'email': 'genevieve.giraldeau@umontreal.ca', 'phone': '514-376-3330', 'phoneExt': '3858'}, {'name': 'Genevieve Giraldeau, MD', 'role': 'CONTACT'}], 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4J 1C5', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Leila Laroussi, MD', 'role': 'CONTACT', 'email': 'liloularoussi@gmail.com', 'phone': '514-338-2050'}, {'name': 'Leila Laroussi, MD', 'role': 'CONTACT'}], 'facility': 'CIUSSS-Hopital du Sacre-Coeur de Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Mario Senechal, MD', 'role': 'CONTACT', 'email': 'Mario.Senechal@criucpq.ulaval.ca'}, {'name': 'Mario Senechal, MD', 'role': 'CONTACT'}], 'facility': 'Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Felix Ayala-Paredes, MD', 'role': 'CONTACT', 'email': 'felix.ayala-paredes@USherbrooke.ca', 'phone': '819-346-1110', 'phoneExt': '16317'}, {'name': 'Felix Ayala-Paredes, MD', 'role': 'CONTACT'}], 'facility': "CIUSSS de l'Estrie - CHUS - Hôpital Fleurimont", 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': '060-0808', 'city': 'Sapporo', 'state': 'Kita 8, Nishi 5, Kita-Ku', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Toshiyuki Nagai, MD', 'role': 'CONTACT', 'email': 'nagai@med.hokudai.ac.jp'}, {'name': 'Toshiyuki Nagai, MD', 'role': 'CONTACT'}], 'facility': 'Hokkaido University', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Chiba', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Y Koboyashi, MD', 'role': 'CONTACT'}, {'name': 'Y Koboyashi', 'role': 'CONTACT'}], 'facility': 'Chiba University', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Fukui', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'H Tada, MD', 'role': 'CONTACT'}], 'facility': 'University of Fukui', 'geoPoint': {'lat': 34.84214, 'lon': 135.54836}}, {'city': 'Kawasaki', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Y. Akashi, MD', 'role': 'CONTACT'}, {'name': 'Y Akashi, MD', 'role': 'CONTACT'}], 'facility': 'St. Marrianna University', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'city': 'Nagoya', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'K Nakasuka, MD', 'role': 'CONTACT', 'email': 'kosuke.nakasuka@gmail.com'}, {'name': 'K Nakasuka, MD', 'role': 'CONTACT'}], 'facility': 'Nagoya City University', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kengo Kusano, MD', 'role': 'CONTACT', 'email': 'kusanokengo@gmail.com'}, {'name': 'Kengo Kusano, MD', 'role': 'CONTACT'}], 'facility': 'National Cerebral and Cardiovascular Center (NCVC)', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Sapporo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Toshiyuki Yano, MD', 'role': 'CONTACT', 'email': 'tyano@sapmed.ac.jp'}, {'name': 'Toshiyuki Yano, MD', 'role': 'CONTACT'}], 'facility': 'Sapporo Medical University', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kenji Yodogawa, MD', 'role': 'CONTACT', 'email': 'yodo@nms.ac.jp'}, {'name': 'Kenji Yodagawa, MD', 'role': 'CONTACT'}], 'facility': 'Nippon Medical School', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': 'SE5 9RS', 'city': 'London', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Francis D Murgatroyd, MD', 'role': 'CONTACT', 'email': 'francis.murgatroyd@nhs.net', 'phone': '+44 (0)20 32993217'}, {'name': 'Francis D Murgatroyd, MD', 'role': 'CONTACT'}], 'facility': "King's College Hospital NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W12 0HS', 'city': 'London', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Amanda Varnava, MD', 'role': 'CONTACT', 'email': 'amanda.varnava@nhs.net'}, {'name': 'Amanda Varnava, MD', 'role': 'CONTACT'}], 'facility': 'Imperial College Healthcare Trust-NHS-Hammersmith Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'David H Birnie, MD', 'role': 'CONTACT', 'email': 'dbirnie@ottawaheart.ca', 'phone': '613-696-7269'}, {'name': 'Janine Ryan, BAH, CCRP', 'role': 'CONTACT', 'email': 'jryan@ottawaheart.ca', 'phone': '613-696-7000', 'phoneExt': '17077'}], 'overallOfficials': [{'name': 'David H Birnie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Heart Institute Research Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Heart Institute Research Corporation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}