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Clinical Trials/NCT03554057
NCT03554057
Completed
Not Applicable

Coronary Computed Tomographic Angiography to Optimize the Diagnostic Yield of Invasive Angiography in Lower Risk Patients

Hamilton Health Sciences Corporation1 site in 1 country186 target enrollmentJuly 9, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Hamilton Health Sciences Corporation
Enrollment
186
Locations
1
Primary Endpoint
Diagnostic yield of invasive angiography
Status
Completed
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
July 9, 2018
End Date
March 1, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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 Outcomes

  • Protocol deviation as a surrogate for acceptability of the novel triage program(Three years)
  • Costing of new strategy(Three years)
  • Quantitative assessment of angiograms avoided(Three years)
  • Deviation from management recommendations following CCTA(Three years)

Study Sites (1)

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