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CCTA to Optimize the Diagnostic Yield of Invasive Angiography

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03554057
Acronym
CarDIA
Enrollment
186
Registered
2018-06-12
Start date
2018-07-09
Completion date
2022-03-01
Last updated
2022-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Angiogram, Coronary Computed Tomographic Angiography

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

Interventions

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

Sponsors

Hamilton Academic Health Sciences Organization
CollaboratorOTHER
Hamilton Health Sciences Corporation
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic yield of invasive angiographyThree yearsDiagnostic 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

MeasureTime frameDescription
Quantitative assessment of angiograms avoidedThree yearsNumber of angiograms avoided due to CCTA bookings
Deviation from management recommendations following CCTAThree yearsNumber of angiograms performed when not recommended
Protocol deviation as a surrogate for acceptability of the novel triage programThree yearsPercentage of patients and physicians refusing to undergo CCTA as a first step
Costing of new strategyThree yearsCost of risk stratification of Coronary Artery Disease in low risk patients

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026