CCTA to Optimize the Diagnostic Yield of Invasive Angiography (CarDIA)

• ClinicalTrials.gov Identifier: NCT03554057
• Recruitment Status: Recruiting
• First Posted: June 12, 2018
• Last Update Posted: January 27, 2021
• Sponsor: Hamilton Health Sciences Corporation
• Collaborator: Hamilton Academic Health Sciences Organization
• Information provided by (Responsible Party): Hamilton Health Sciences Corporation

Study Description

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

Condition or disease	Intervention/treatment
Coronary Artery Disease	Diagnostic Test: Coronary Computed Tomographic Angiography

Study Design

• Study Type: Observational
• Estimated Enrollment: 720 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Coronary Computed Tomographic Angiography to Optimize the Diagnostic Yield of Invasive Angiography in Lower Risk Patients
• Actual Study Start Date: July 9, 2018
• Estimated Primary Completion Date: September 30, 2021
• Estimated Study Completion Date: September 30, 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
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; 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
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

Outcome Measures

Primary Outcome Measures :

1. Diagnostic yield of invasive angiography [ Time Frame: Three years ]
   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)

Secondary Outcome Measures :

1. Quantitative assessment of angiograms avoided [ Time Frame: Three years ]
   Number of angiograms avoided due to CCTA bookings
2. Deviation from management recommendations following CCTA [ Time Frame: Three years ]
   Number of angiograms performed when not recommended
3. Protocol deviation as a surrogate for acceptability of the novel triage program [ Time Frame: Three years ]
   Percentage of patients and physicians refusing to undergo CCTA as a first step
4. Costing of new strategy [ Time Frame: Three years ]
   Cost of risk stratification of Coronary Artery Disease in low risk patients

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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).

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)

Contacts and Locations

Contacts

Contact: Jon-David Schwalm, MD,FRCPC,Msc; 905 577 1423; schwalj@mcmaster.ca

Contact: Tara McCready, PhD, MBA; 905 527 0271; Tara.McCready@phri.ca

Locations

Canada, Ontario

Hamilton General Hospital; Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contact: Jon-David Schwalm, MD

Sponsors and Collaborators

Hamilton Health Sciences Corporation

Hamilton Academic Health Sciences Organization

Investigators

• Principal Investigator: Jon-David Schwalm, MD,FRCPC,Msc; Hamilton Health Sciences Corporation
• Principal Investigator: Tej Sheth, Bsc,FRCPC,MD; Hamilton Health Sciences Corporation

More Information

Publications:

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.

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. Erratum in: N Engl J Med. 2010 Jul 29;363(5):498.

Ouellette ML, Beller GA, Löffler 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.

Dewey M, Rief M, Martus P, Kendziora B, Feger S, Dreger H, Priem S, Knebel F, Böhm M, Schlattmann P, Hamm B, Schönenberger 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. Erratum in: BMJ. 2016 Nov 29;355:i6420.

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.

• Responsible Party: Hamilton Health Sciences Corporation
• ClinicalTrials.gov Identifier: NCT03554057
• Other Study ID Numbers: 4697
• First Posted: June 12, 2018
• Last Update Posted: January 27, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hamilton Health Sciences Corporation:

Angiogram, Coronary Computed Tomographic Angiography

Additional relevant MeSH terms:

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