CCTA to Optimize the Diagnostic Yield of Invasive Angiography

Completed

• Conditions: Coronary Artery Disease
• Interventions: Diagnostic Test: Coronary Computed Tomographic Angiography

• Registration Number: NCT03554057
• Lead Sponsor: Hamilton Health Sciences Corporation

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-30
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-06-12
• Study Start: 2018-07-09
• Primary Completion: 2020-02-28
• Status Verified: 2022-03
• Study Completion: 2022-03-01
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention Group	Coronary Computed Tomographic Angiography	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.

Primary Outcome Measures

Name	Time	Method
Diagnostic yield of invasive angiography	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

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

Trial Locations

Locations (1)

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada