NCT03554057|Completed
CCTA to Optimize the Diagnostic Yield of Invasive Angiography
CarDIA
Coronary Computed Tomographic Angiography to Optimize the Diagnostic Yield of Invasive Angiography in Lower Risk Patients
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CarDIA
Coronary Computed Tomographic Angiography to Optimize the Diagnostic Yield of Invasive Angiography in Lower Risk Patients
Sponsor study identifier
observational
186
1 country
1
Study Start
July 9, 2018
Actual (reported)Primary Completion
February 28, 2020
Actual (reported)Study Completion
March 1, 2022
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 30, 2018
Actual (reported)June 12, 2018
Actual (reported)July 9, 2018
Actual (reported)February 28, 2020
Actual (reported)March 1, 2022
Actual (reported)Diagnostic yield of invasive angiography
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)
Three years
Quantitative assessment of angiograms avoided
Three years
Deviation from management recommendations following CCTA
Three years
Protocol deviation as a surrogate for acceptability of the novel triage program
Three years
Costing of new strategy
Three years
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.
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
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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).
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
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.
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.
Jon-David Schwalm, MD,FRCPC,Msc
Hamilton Health Sciences Corporation
Tej Sheth, Bsc,FRCPC,MD
Hamilton Health Sciences Corporation
186 participants (actual enrollment reported by the registry).
First Submitted
May 30, 2018
First Posted
June 12, 2018
Study Start
July 9, 2018
Actual (reported)Optina Eye to Heart Connection
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Primary Completion
February 28, 2020
Actual (reported)Study Completion
March 1, 2022
Actual (reported)Last Updated
March 16, 2022
Record last verified: 2022-03
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Source: ClinicalTrials.gov.
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