Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT04367220
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2020-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiovascular Imaging Registry of Canada
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2030-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2020-04-26', 'studyFirstSubmitQcDate': '2020-04-26', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiovascular outcomes (MACE)', 'timeFrame': '2024', 'description': 'Composite of all-cause death, heart failure admission, myocardial infarction, heart transplantation or LVAD, Stroke or TIA'}, {'measure': 'Malignant arrhythmic events', 'timeFrame': '2024', 'description': 'Composite of sudden cardiac death or appropriate ICD shock'}, {'measure': 'Heart failure events', 'timeFrame': '2024', 'description': 'Composite of heart failure admission, death or need for transplantation / LVAD'}, {'measure': 'Atrial arrhythmic events', 'timeFrame': '2024', 'description': 'Occurrence of atrial fibrillation / atrial flutter (documented by 12-lead ECG or Holter monitor)'}, {'measure': 'All-cause mortality', 'timeFrame': '2024', 'description': 'Death based on Vital Statistics Alberta and In-hospital coded death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '33722059', 'type': 'DERIVED', 'citation': 'Purmah Y, Lei LY, Dykstra S, Mikami Y, Cornhill A, Satriano A, Flewitt J, Rivest S, Sandonato R, Seib M, Lydell CP, Howarth AG, Heydari B, Merchant N, Bristow M, Fine N, Gaztanaga J, White JA. Right Ventricular Ejection Fraction for the Prediction of Major Adverse Cardiovascular and Heart Failure-Related Events: A Cardiac MRI Based Study of 7131 Patients With Known or Suspected Cardiovascular Disease. Circ Cardiovasc Imaging. 2021 Mar;14(3):e011337. doi: 10.1161/CIRCIMAGING.120.011337. Epub 2021 Mar 16.'}]}, 'descriptionModule': {'briefSummary': 'A multi-site, multi-modality prospective observational clinical outcomes study focussed on the development of phenotype-dirven risk prediction modelling in patients with known or suspected cardiovascular disease.', 'detailedDescription': 'The Cardiovascular Imaging Registry of Canada (CIROC) was conceived to provide a common standardized architecture for the collection of clinically reported imaging biomarkers, demographic information, resource utilization and clinical outcomes among patients referred to non-invasive cardiac imaging. The Registry was designed to assess the feasibility of implementing personalized care strategies through automated high quality data collection and patient engagement.\n\nThe CIROC Registry was launched with inaugural focus on Cardiac MRI base phenotyping, however has evolved to encompass cardiac CTA and echocardiography. Clinically referred patients are engaged by automated, tablet-based tools to collect informed consent and deploy standardized patient health assessments. Standardized reporting of disease features are captured using bespoke reporting tools. All patients are prospectively followed for a period of 10-years using linkage to administrative health data, inclusive of ICD-coded events, laboratory test results, ECG and vital statistics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients referred for hospital based cardiac imaging services are considered eligible and are routinely approached using automated patient engagement tools and consent management services.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients referred for hospital-based cardiac imaging services\n\nExclusion Criteria:\n\n* Failure or provide informed consent'}, 'identificationModule': {'nctId': 'NCT04367220', 'acronym': 'CIROC', 'briefTitle': 'Cardiovascular Imaging Registry of Canada', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Cardiovascular Imaging Registry of Canada', 'orgStudyIdInfo': {'id': 'REB13-0902'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with known or suspected cardiovascular disease', 'description': 'All patients with known or suspected cardiovascular disease are studied with a-priori stratification of specific disease-based cohorts.', 'interventionNames': ['Diagnostic Test: Diagnostic testing performed as per routine care']}], 'interventions': [{'name': 'Diagnostic testing performed as per routine care', 'type': 'DIAGNOSTIC_TEST', 'armGroupLabels': ['Patients with known or suspected cardiovascular disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N2T9', 'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'James A White, MD', 'role': 'CONTACT'}], 'facility': 'Foothills Medical Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T3M1M4', 'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'James A White, MD', 'role': 'CONTACT'}], 'facility': 'South Health Campus', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'James A White, MD', 'role': 'CONTACT'}], 'facility': 'Peter Lougheed Hospital', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'James A White, MD', 'role': 'CONTACT'}], 'facility': 'Rockyview Hospital', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'centralContacts': [{'name': 'James White', 'role': 'CONTACT', 'email': 'jawhit@ucalgary.ca', 'phone': '403-944-2805'}, {'name': 'Sandra Rivest', 'role': 'CONTACT', 'email': 'sandra.rivest@ahs.ca', 'phone': '403-944-1961'}], 'overallOfficials': [{'name': 'James White', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director of Stephenson Cardiac Imaging Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alberta Health services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, FRCP(C) Director - Stephenson Cardiac Imaging Centre', 'investigatorFullName': 'James White', 'investigatorAffiliation': 'University of Calgary'}}}}