Clinical trial NCT03554057: CCTA to Optimize the Diagnostic Yield of Invasive Angiography
Official title: Coronary Computed Tomographic Angiography to Optimize the Diagnostic Yield of Invasive Angiography in Lower Risk Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Angiogram, Coronary Computed Tomographic Angiography
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: Hamilton Academic Health Sciences Organization
First posted: 2018-06-12
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

1. Non urgent outpatient referral
2. Canadian Cardiovascular Society class I or II
3. Indication for invasive angiogram includes: Rule out Coronary Artery Disease (CAD) and Cardiomyopathy

Exclusion Criteria:

1. Age \<18 years old, Men \>65 years old or women \>75 years old
2. Patient refusal to provide verbal consent for CCTA at time of triage contact or unable to provide informed consent
3. Referring physician refusal for their eligible patients to be approached for the CarDIA study
4. Any prior CCTA
5. Atrial Fibrillation
6. Creatinine \> 150 mmol/L
7. Diabetes mellitus
8. High risk Exercise Stress Test or Functional Imaging
9. Known severe valvular disease being considered for valve surgery
10. Any known CAD

    * Prior Acute Coronary Syndrome (ACS)
    * Prior Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG)

Primary outcomes:
measure: Diagnostic yield of invasive angiography
timeFrame: Three years
Secondary outcomes:
measure: Quantitative assessment of angiograms avoided
timeFrame: Three years
measure: Deviation from management recommendations following CCTA
timeFrame: Three years
measure: Protocol deviation as a surrogate for acceptability of the novel triage program
timeFrame: Three years
measure: Costing of new strategy
timeFrame: Three years
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Jon-David Schwalm, MD,FRCPC,Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hamilton Health Sciences Corporation
name: Tej Sheth, Bsc,FRCPC,MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.
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.