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Trial record 1 of 3 for:    20220183 [PUBMED-IDS]
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CCTA to Optimize the Diagnostic Yield of Invasive Angiography (CarDIA)

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ClinicalTrials.gov Identifier: NCT03554057
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Hamilton Academic Health Sciences Organization
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Coronary Artery Disease Diagnostic Test: Coronary Computed Tomographic Angiography

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Study Type : Observational
Estimated Enrollment : 720 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Coronary Computed Tomographic Angiography to Optimize the Diagnostic Yield of Invasive Angiography in Lower Risk Patients
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 31, 2021

Group/Cohort Intervention/treatment
Intervention Group
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.
Diagnostic Test: Coronary Computed Tomographic Angiography
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

Control Group
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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All eligible low-risk patients referred for invasive angiography will be recruited from the two interventional sites (approximately 240) via centralized triage process. Patients treated before the intervention implementation will be the control group (approximately 480).
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554057


Contacts
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Contact: Jon-David Schwalm, MD,FRCPC,Msc 905 577 1423 schwalj@mcmaster.ca
Contact: Tara McCready, PhD, MBA 905 527 0271 Tara.McCready@phri.ca

Locations
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Canada, Ontario
Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Jon-David Schwalm, MD         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Hamilton Academic Health Sciences Organization
Investigators
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Principal Investigator: Jon-David Schwalm, MD,FRCPC,Msc Hamilton Health Sciences Corporation
Principal Investigator: Tej Sheth, Bsc,FRCPC,MD Hamilton Health Sciences Corporation

Publications:

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Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT03554057     History of Changes
Other Study ID Numbers: 4697
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hamilton Health Sciences Corporation:
Angiogram, Coronary Computed Tomographic Angiography

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases