CCTA to Optimize the Diagnostic Yield of Invasive Angiography

NCT03554057 | Completed

• 1 other identifier: 4697
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Disease

Keywords

Angiogram, Coronary Computed Tomographic Angiography

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

Study Arms (2)

Intervention Group

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.

Diagnostic Test: Coronary Computed Tomographic Angiography

Control Group

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

Coronary Computed Tomographic Angiography DIAGNOSTIC_TEST

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

Intervention Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• Age \<18 years old, Men \>65 years old or women \>75 years old
• Patient refusal to provide verbal consent for CCTA at time of triage contact or unable to provide informed consent
• Referring physician refusal for their eligible patients to be approached for the CarDIA study
• Any prior CCTA
• Atrial Fibrillation
• Creatinine \> 150 mmol/L
• Diabetes mellitus
• High risk Exercise Stress Test or Functional Imaging
• Known severe valvular disease being considered for valve surgery
• Any known CAD
• Prior Acute Coronary Syndrome (ACS)
• Prior Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG)

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Hamilton Academic Health Sciences Organization: collaborator

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (6)

• 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: 25830423 BACKGROUND

• 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: 18440342 BACKGROUND

• 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: 20220183 BACKGROUND

• 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: 28545644 BACKGROUND

• 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: 27777234 BACKGROUND

• 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.

  PMID: 21640554 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jon-David Schwalm, MD,FRCPC,Msc

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

• Tej Sheth, Bsc,FRCPC,MD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 12, 2018
• Study Start: July 9, 2018
• Primary Completion: February 28, 2020
• Study Completion: March 1, 2022
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)