Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-29 @ 1:11 PM
Study NCT ID:
NCT03398850
Status:
RECRUITING
Last Update Posted:
2018-01-17
First Post:
2017-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spontaneous Coronary Artery Dissection anaLysIs of the Brazilian Updated Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C565153', 'term': 'Coronary Artery Dissection, Spontaneous'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2000-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-12', 'studyFirstSubmitDate': '2017-12-29', 'studyFirstSubmitQcDate': '2018-01-11', 'lastUpdatePostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-term clinical outcomes in patients presented with spontaneous coronary artery dissection', 'timeFrame': '10 years', 'description': 'All major adverse cardiac events will be collected'}], 'secondaryOutcomes': [{'measure': 'Multimodality intravascular imaging findings in patients with spontaneous coronary artery dissection.', 'timeFrame': '10 years', 'description': 'Multimodality intravascular imaging will be recorded'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spontaneous coronary artery dissection', 'acute coronary syndrome', 'coronary angiography', 'coronary tomography'], 'conditions': ['Coronary Artery Dissection, Spontaneous']}, 'referencesModule': {'references': [{'pmid': '27383563', 'type': 'BACKGROUND', 'citation': 'Cade J, Mintz GS, Silva RM Filho, Caixeta A. Spontaneous coronary artery dissection and healing documented by optical coherence tomography. Einstein (Sao Paulo). 2016 Jul-Sep;14(3):435-436. doi: 10.1590/S1679-45082016AI3551. Epub 2016 Jul 4. No abstract available.'}, {'pmid': '25457056', 'type': 'BACKGROUND', 'citation': 'Cade JR, Abizaid A, Caixeta A. Organized thrombus mimicking spontaneous coronary artery dissection. JACC Cardiovasc Interv. 2014 Dec;7(12):1458. doi: 10.1016/j.jcin.2014.08.004. Epub 2014 Nov 12. No abstract available.'}, {'pmid': '28302643', 'type': 'BACKGROUND', 'citation': 'Saw J. Pregnancy-Associated Spontaneous Coronary Artery Dissection Represents an Exceptionally High-Risk Spontaneous Coronary Artery Dissection Cohort. Circ Cardiovasc Interv. 2017 Mar;10(3):e005119. doi: 10.1161/CIRCINTERVENTIONS.117.005119. No abstract available.'}, {'pmid': '24227590', 'type': 'BACKGROUND', 'citation': 'Saw J. Coronary angiogram classification of spontaneous coronary artery dissection. Catheter Cardiovasc Interv. 2014 Dec 1;84(7):1115-22. doi: 10.1002/ccd.25293. Epub 2013 Dec 4.'}, {'pmid': '23266235', 'type': 'BACKGROUND', 'citation': 'Saw J, Ricci D, Starovoytov A, Fox R, Buller CE. Spontaneous coronary artery dissection: prevalence of predisposing conditions including fibromuscular dysplasia in a tertiary center cohort. JACC Cardiovasc Interv. 2013 Jan;6(1):44-52. doi: 10.1016/j.jcin.2012.08.017. Epub 2012 Dec 19.'}, {'pmid': '26928981', 'type': 'RESULT', 'citation': 'Cade JR, Szarf G, de Siqueira ME, Chaves A, Andrea JC, Figueira HR, Gomes MM Jr, Freitas BP, Filgueiras Medeiros J, Dos Santos MR, Fiorotto WB, Daige A, Goncalves R, Cantarelli M, Alves CM, Echenique L, de Brito FS Jr, Perin MA, Born D, Hecht H, Caixeta A. Pregnancy-associated spontaneous coronary artery dissection: insights from a case series of 13 patients. Eur Heart J Cardiovasc Imaging. 2017 Jan;18(1):54-61. doi: 10.1093/ehjci/jew021. Epub 2016 Feb 28.'}]}, 'descriptionModule': {'briefSummary': 'A retrospective and prospective registry will evaluate demographic and angiographic data in patients with spontaneous coronary artery dissection (SCAD) using medical records, invasive coronary angiography, intravascular imaging and/or computed multislice coronary tomography. The type of treatment applied during index hospitalization (i.e., clinical management, percutaneous coronary intervention or coronary artery bypass grafting) will be evaluated. Long-term follow-up (up to 10 years) will be also reported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The present study population will be selected retrospectively and prospectively from several Brazilian tertiary Hospitals. Clinical data and coronary imaging will be imputed through electronic case report form (eCRF), which will be kept confidential at dedicated server at the Coordinator Center, Hospital Israelita Albert Einstein.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with coronary manifestations due spontaneous coronary artery dissection\n* Angiographic findings of SCAD in coronary angiogram or coronary tomography\n* Agreement between two or more invasive cardiologists (adjudicated committee) for the diagnosis.\n\nExclusion Criteria:\n\n* Non-agreement for SCAD diagnosis\n* Coronary dissections due other mechanisms: unstable atherosclerotic plaque or trauma-induced.'}, 'identificationModule': {'nctId': 'NCT03398850', 'acronym': 'SCALIBUR', 'briefTitle': 'Spontaneous Coronary Artery Dissection anaLysIs of the Brazilian Updated Registry', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Israelita Albert Einstein'}, 'officialTitle': 'Spontaneous Coronary Artery Dissection anaLysIs of the Brazilian Updated Registry: Epidemiological Data, Clinical Results and Long-Term Follow-up (SCALIBUR Registry).', 'orgStudyIdInfo': {'id': 'SCALIBUR Registry'}}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Carolina Pereira, RN', 'role': 'CONTACT'}], 'facility': 'Hospital Israelita Albert Einstein', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Carolina Pereira, RN', 'role': 'CONTACT', 'email': 'carolinap@einstein.br', 'phone': '+551121519408'}], 'overallOfficials': [{'name': 'Jamil Cade, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Israelita Albert Einstein'}, {'name': 'Adriano Caixeta, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Israelita Albert Einstein'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'The first data will be available by 2019', 'ipdSharing': 'YES', 'description': 'Data from this observational registry will be shared with others researchers and presented at medical conferences.', 'accessCriteria': 'All researchers will be have the data available upon requested'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Israelita Albert Einstein', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Adriano Caixeta', 'investigatorAffiliation': 'Hospital Israelita Albert Einstein'}}}}