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

Hamilton Health Sciences (HHS)

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Diagnostic Test: Coronary Computed Tomographic Angiography

Study type: Observational

Funder types: Other

Identifiers

NCT03554057

4697

Details and patient eligibility

About

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

Enrollment: 186 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

186 participants in 2 patient groups

Intervention Group

Description:

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.

Treatment:

Diagnostic Test: Coronary Computed Tomographic Angiography

Control Group

Description:

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