Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-01-03 @ 10:57 PM
Study NCT ID:
NCT03554057
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2018-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CCTA to Optimize the Diagnostic Yield of Invasive Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-14', 'studyFirstSubmitDate': '2018-05-30', 'studyFirstSubmitQcDate': '2018-05-30', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic yield of invasive angiography', 'timeFrame': 'Three years', 'description': 'Diagnostic yield is defined as the proportion of invasive angiograms that identify significant disease (≥70% stenosis) on a major coronary vessel (\\>2 mm) or \\> 50% stenosis in the left main)'}], 'secondaryOutcomes': [{'measure': 'Quantitative assessment of angiograms avoided', 'timeFrame': 'Three years', 'description': 'Number of angiograms avoided due to CCTA bookings'}, {'measure': 'Deviation from management recommendations following CCTA', 'timeFrame': 'Three years', 'description': 'Number of angiograms performed when not recommended'}, {'measure': 'Protocol deviation as a surrogate for acceptability of the novel triage program', 'timeFrame': 'Three years', 'description': 'Percentage of patients and physicians refusing to undergo CCTA as a first step'}, {'measure': 'Costing of new strategy', 'timeFrame': 'Three years', 'description': 'Cost of risk stratification of Coronary Artery Disease in low risk patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Angiogram, Coronary Computed Tomographic Angiography'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '25830423', 'type': 'BACKGROUND', 'citation': 'Roth GA, Forouzanfar MH, Moran AE, Barber R, Nguyen G, Feigin VL, Naghavi M, Mensah GA, Murray CJ. Demographic and epidemiologic drivers of global cardiovascular mortality. N Engl J Med. 2015 Apr 2;372(14):1333-41. doi: 10.1056/NEJMoa1406656.'}, {'pmid': '18440342', 'type': 'BACKGROUND', 'citation': 'Sheth T, Amlani S, Ellins ML, Mehta S, Velianou J, Cappelli G, Yang S, Natarajan M. Computed tomographic coronary angiographic assessment of high-risk coronary anatomy in patients with suspected coronary artery disease and intermediate pretest probability. Am Heart J. 2008 May;155(5):918-23. doi: 10.1016/j.ahj.2007.11.035. Epub 2008 Feb 19.'}, {'pmid': '20220183', 'type': 'BACKGROUND', 'citation': 'Patel MR, Peterson ED, Dai D, Brennan JM, Redberg RF, Anderson HV, Brindis RG, Douglas PS. Low diagnostic yield of elective coronary angiography. N Engl J Med. 2010 Mar 11;362(10):886-95. doi: 10.1056/NEJMoa0907272.'}, {'pmid': '28545644', 'type': 'BACKGROUND', 'citation': 'Ouellette ML, Beller GA, Loffler AI, Workman VK, Bourque JM. Appropriate Referrals of Angiography Despite High Prevalence of Normal Coronary Arteries or Nonobstructive CAD. J Am Coll Cardiol. 2017 May 30;69(21):2673-2675. doi: 10.1016/j.jacc.2017.03.565. No abstract available.'}, {'pmid': '27777234', 'type': 'BACKGROUND', 'citation': 'Dewey M, Rief M, Martus P, Kendziora B, Feger S, Dreger H, Priem S, Knebel F, Bohm M, Schlattmann P, Hamm B, Schonenberger E, Laule M, Zimmermann E. Evaluation of computed tomography in patients with atypical angina or chest pain clinically referred for invasive coronary angiography: randomised controlled trial. BMJ. 2016 Oct 24;355:i5441. doi: 10.1136/bmj.i5441.'}, {'pmid': '21640554', 'type': 'BACKGROUND', 'citation': 'Zhang F, Wagner AK, Ross-Degnan D. Simulation-based power calculation for designing interrupted time series analyses of health policy interventions. J Clin Epidemiol. 2011 Nov;64(11):1252-61. doi: 10.1016/j.jclinepi.2011.02.007.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to reduce patient risk and costs to the healthcare system by improving the diagnostic yield of invasive coronary angiography through existing triage processes to improve risk stratification using Coronary Computed Tomographic Angiography (CCTA) as a first step in low risk patients. All low-risk patients referred for invasive coronary angiography will be potentially eligible for CCTA instead of invasive angiography as a first-line diagnostic test. All CCTAs will be read by both a level 3-trained cardiologist and a radiologist. The results of the CCTA, coupled with evidence-based management recommendations will be sent to the referring physician and an invasive angiogram will be arranged by the HIU triage, only when clearly indicated'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All eligible low-risk patients referred for invasive angiography will be recruited from the two interventional sites (approximately 240) via centralized triage process. Patients treated before the intervention implementation will be the control group (approximately 480).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Non urgent outpatient referral\n2. Canadian Cardiovascular Society class I or II\n3. Indication for invasive angiogram includes: Rule out Coronary Artery Disease (CAD) and Cardiomyopathy\n\nExclusion Criteria:\n\n1. Age \\<18 years old, Men \\>65 years old or women \\>75 years old\n2. Patient refusal to provide verbal consent for CCTA at time of triage contact or unable to provide informed consent\n3. Referring physician refusal for their eligible patients to be approached for the CarDIA study\n4. Any prior CCTA\n5. Atrial Fibrillation\n6. Creatinine \\> 150 mmol/L\n7. Diabetes mellitus\n8. High risk Exercise Stress Test or Functional Imaging\n9. Known severe valvular disease being considered for valve surgery\n10. Any known CAD\n\n * Prior Acute Coronary Syndrome (ACS)\n * Prior Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG)'}, 'identificationModule': {'nctId': 'NCT03554057', 'acronym': 'CarDIA', 'briefTitle': 'CCTA to Optimize the Diagnostic Yield of Invasive Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Hamilton Health Sciences Corporation'}, 'officialTitle': 'Coronary Computed Tomographic Angiography to Optimize the Diagnostic Yield of Invasive Angiography in Lower Risk Patients', 'orgStudyIdInfo': {'id': '4697'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention Group', 'description': "All low-risk patients referred for invasive coronary angiography through the Hamilton General Hospital's Heart Investigation Unit Triage will be potentially eligible to receive the intervention over a 12-month period. The intervention will include risk stratification with CCTA at HHS and NHS as an alternative to upfront invasive angiography.", 'interventionNames': ['Diagnostic Test: Coronary Computed Tomographic Angiography']}, {'label': 'Control Group', 'description': 'Intervention sites will act as their own controls: outcomes of all eligible patients in the 24-months prior to the implementation of the intervention will be assessed from a routinely collected health administrative database. Eligible patients not undergoing CCTA (patient or physician refusal, or CCTA not available) will be captured and included in the control group as part of a sensitivity analysis during the intervention period'}], 'interventions': [{'name': 'Coronary Computed Tomographic Angiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'All low-risk patients referred for invasive coronary angiography will be potentially eligible to receive the intervention over a 12-month period. The intervention will include risk stratification using Coronary Computed Tomographic Angiography (CCTA) at HHS and NHS as an alternative to upfront invasive angiography. All CCTAs will be read by both a level 3-trained cardiologist and a radiologist. The results of the CCTA, coupled with evidence-based management recommendations will be sent to the referring physician and an invasive angiogram will be arranged only when indicated as per these management recommendations', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton General Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Jon-David Schwalm, MD,FRCPC,Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hamilton Health Sciences Corporation'}, {'name': 'Tej Sheth, Bsc,FRCPC,MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hamilton Health Sciences Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hamilton Academic Health Sciences Organization', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}