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Completed

NCT Number: NCT03554057

CCTA to Optimize the Diagnostic Yield of Invasive Angiography

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

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Prior Acute Coronary Syndrome (ACS)
  • Prior Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG)

Treatment and study plan

Coronary Computed Tomographic Angiography

Diagnostic Test

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • Hamilton Academic Health Sciences Organization

Registry information

Official study title

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

Acronym: CarDIA

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Jun 12, 2018
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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