Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-01 @ 9:47 PM
Study NCT ID:
NCT04906356
Status:
RECRUITING
Last Update Posted:
2021-05-28
First Post:
2021-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Canadian SCAD Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C565153', 'term': 'Coronary Artery Dissection, Spontaneous'}, {'id': 'D005352', 'term': 'Fibromuscular Dysplasia'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D000088442', 'term': 'MINOCA'}], 'ancestors': [{'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva DNA sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2033-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-25', 'studyFirstSubmitDate': '2021-04-16', 'studyFirstSubmitQcDate': '2021-05-25', 'lastUpdatePostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-hospital CV outcomes', 'timeFrame': 'From date of hospital admission to discharge up to 8 weeks', 'description': 'Composite (Death, MI, CVA, Unplanned revascularization, Heart failure)'}, {'measure': 'Long-term CV outcomes', 'timeFrame': 'at 10 Years post index event', 'description': 'Composite (Death, MI, CVA, Revascularization, Heart failure)'}], 'secondaryOutcomes': [{'measure': 'Arterial healing post SCAD', 'timeFrame': 'at 6 weeks post discharge post index event', 'description': 'Angiographic healing'}, {'measure': 'Coronary revascularization success', 'timeFrame': 'During index hospitalization', 'description': 'Composite (TIMI 3 flow, \\<50% stenosis, and no residual dissection)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fibromuscular displasia (FMD)', 'Myocardial Infarction', 'Myocardial Infarction in women', 'Non-atherosclerotic coronary artery disease (NACAD)', 'Myocardial Infarction with no obstructive coronary artery disease (MINOCA)', 'SCAD', 'Spontaneous Coronary Artery Dissection'], 'conditions': ['Spontaneous Coronary Artery Dissection', 'SCAD', 'Fibromuscular Dysplasia']}, 'referencesModule': {'references': [{'pmid': '30698711', 'type': 'RESULT', 'citation': 'Saw J, Starovoytov A, Humphries K, Sheth T, So D, Minhas K, Brass N, Lavoie A, Bishop H, Lavi S, Pearce C, Renner S, Madan M, Welsh RC, Lutchmedial S, Vijayaraghavan R, Aymong E, Har B, Ibrahim R, Gornik HL, Ganesh S, Buller C, Matteau A, Martucci G, Ko D, Mancini GBJ. Canadian spontaneous coronary artery dissection cohort study: in-hospital and 30-day outcomes. Eur Heart J. 2019 Apr 14;40(15):1188-1197. doi: 10.1093/eurheartj/ehz007.'}]}, 'descriptionModule': {'briefSummary': 'Natural history multicenter, prospective, observational registry with 10-year follow-up', 'detailedDescription': 'Spontaneous coronary artery dissection (SCAD) is an under-diagnosed and poorly understood condition that frequently affects young women without conventional cardiovascular (CV) risk factors and can result in myocardial infarction (MI), cardiac arrest, and death. This condition has not been adequately studied, and there are no randomized controlled trials to guide treatment. Furthermore, SCAD has been frequently misdiagnosed due to the current "gold-standard" coronary angiography limitations. As such, there are uncertainties with the diagnosis and management of SCAD patients. Therefore, the investigators propose a large prospective multicenter Canadian SCAD Study to ascertain the natural history of predisposing arteriopathies and treatment strategy on short and long-term CV outcomes to design future randomized controlled trials.\n\nThis is a multicenter, prospective, international, observational natural history study with a planned total enrolment of 3,000 patients with SCAD. The investigators plan to recruit patients from major cardiac catheterization centers across Canada and several centers in the United States and internationally. The research team successfully enrolled 750 patients prospectively in the "Canadian SCAD Cohort Study" from 22 sites in North America. This current study will be an extension of that study, now named the "Canadian SCAD Study." It will continue enrolment for a total of 3,000 patients internationally (from \\>35 sites). Detailed baseline demographics, targeted history for precipitating stressors and predisposing conditions, and investigations for predisposing conditions will be performed during the study. Patients will be prospectively followed long-term for up to 10 years for CV events. The study is approved, allowing potential participants to be enrolled using an electronic consent form irrespective of their geographic location and directly communicating with the study team at UBC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted with ACS (STEMI, NSTEMI or unstable angina) and diagnosed with SCAD during direct coronary angiography. The study imaging corelab will review all films before participant enrollment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients admitted with ACS (STEMI, NSTEMI or unstable angina)\n2. Documented SCAD on a coronary angiogram (including diagnosis with OCT or IVUS)\n\nExclusion Criteria:\n\n1\\. Patients where SCAD is attributed to atherosclerotic coronary artery disease, with atherosclerotic coronary artery disease stenosis ≥50%'}, 'identificationModule': {'nctId': 'NCT04906356', 'briefTitle': 'Canadian SCAD Study', 'organization': {'class': 'OTHER', 'fullName': 'Cardiology Research UBC'}, 'officialTitle': 'Canadian Spontaneous Coronary Artery Dissection (SCAD) Study and Genetic Sub-study (Prospective, Observational Registry With 10 Year Follow-up)', 'orgStudyIdInfo': {'id': 'H18-03039'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Single group observational study', 'interventionNames': ['Genetic: Genetic sub-study']}], 'interventions': [{'name': 'Genetic sub-study', 'type': 'GENETIC', 'description': 'One time saliva sample collection', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Johandra Argote Parolis, MD', 'role': 'CONTACT', 'email': 'j.argoteparolis@ubc.ca', 'phone': '604 875 4111', 'phoneExt': '63344'}, {'name': 'Jacqueline Saw, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'John GB Mancini, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Andrew Starovoytov, MD', 'role': 'CONTACT', 'email': 'a.starovoytov@ubc.ca', 'phone': '6048755079'}, {'name': 'Johandra Argote Parolis, MD', 'role': 'CONTACT', 'email': 'j.argoteparolis@ubc.ca', 'phone': '6048754111', 'phoneExt': '63344'}], 'overallOfficials': [{'name': 'Jacqueline Saw, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiology Research UBC / Vancouver General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiology Research UBC', 'class': 'OTHER'}, 'collaborators': [{'name': 'John GB Mancini, MD', 'class': 'UNKNOWN'}, {'name': 'Karin Humphries, DSc', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor of Medicine', 'investigatorFullName': 'Jacqueline Saw, MD', 'investigatorAffiliation': 'Cardiology Research UBC'}}}}