Coronary Artery DiseaseCarDIANCT03554057
CCTA to Optimize the Diagnostic Yield of Invasive Angiography
An observational study of Coronary Artery Disease, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary Computed Tomographic Angiography
- How many people
- 186 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jul 2018to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Non urgent outpatient referral
- Canadian Cardiovascular Society class I or II
- Indication for invasive angiogram includes: Rule out Coronary Artery Disease (CAD) and Cardiomyopathy
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coronary Computed Tomographic Angiography to Optimize the Diagnostic Yield of Invasive Angiography in Lower Risk Patients
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
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary Computed Tomographic Angiography
- Keywords
- Angiogram, Coronary Computed Tomographic Angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Computed Tomographic AngiographyDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Coronary Computed Tomographic Angiography | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of invasive angiography
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)
Measured: Three years
Secondary outcomes (4)
Quantitative assessment of angiograms avoided
Number of angiograms avoided due to CCTA bookings
Measured: Three years
Deviation from management recommendations following CCTA
Number of angiograms performed when not recommended
Measured: Three years
Protocol deviation as a surrogate for acceptability of the novel triage program
Percentage of patients and physicians refusing to undergo CCTA as a first step
Measured: Three years
Costing of new strategy
Cost of risk stratification of Coronary Artery Disease in low risk patients
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start9 Jul 2018
- Primary completion28 Feb 2020
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization
- Responsible party
- Sponsor
- Investigators
- Jon-David Schwalm, MD,FRCPC,Msc, Principal investigator, Hamilton Health Sciences CorporationTej Sheth, Bsc,FRCPC,MD, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554057
- Sponsor's protocol ID
- 4697
- Acronym
- CarDIA
- Status last verified
- Mar 2022
- First submitted
- 30 May 2018
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roth GA, Forouzanfar MH, Moran AE, Barber R, Nguyen G, Feigin VL, Naghavi M, Mensah GA, Murray CJ. Demographic and epidemiologic drivers of global cardiovascular mortality. N Engl J Med. 2015 Apr 2;372(14):1333-41. doi: 10.1056/NEJMoa1406656.
PubMed 25830423Sheth T, Amlani S, Ellins ML, Mehta S, Velianou J, Cappelli G, Yang S, Natarajan M. Computed tomographic coronary angiographic assessment of high-risk coronary anatomy in patients with suspected coronary artery disease and intermediate pretest probability. Am Heart J. 2008 May;155(5):918-23. doi: 10.1016/j.ahj.2007.11.035. Epub 2008 Feb 19.
PubMed 18440342Patel MR, Peterson ED, Dai D, Brennan JM, Redberg RF, Anderson HV, Brindis RG, Douglas PS. Low diagnostic yield of elective coronary angiography. N Engl J Med. 2010 Mar 11;362(10):886-95. doi: 10.1056/NEJMoa0907272.
PubMed 20220183Ouellette ML, Beller GA, Loffler AI, Workman VK, Bourque JM. Appropriate Referrals of Angiography Despite High Prevalence of Normal Coronary Arteries or Nonobstructive CAD. J Am Coll Cardiol. 2017 May 30;69(21):2673-2675. doi: 10.1016/j.jacc.2017.03.565. No abstract available.
PubMed 28545644Dewey M, Rief M, Martus P, Kendziora B, Feger S, Dreger H, Priem S, Knebel F, Bohm M, Schlattmann P, Hamm B, Schonenberger E, Laule M, Zimmermann E. Evaluation of computed tomography in patients with atypical angina or chest pain clinically referred for invasive coronary angiography: randomised controlled trial. BMJ. 2016 Oct 24;355:i5441. doi: 10.1136/bmj.i5441.
PubMed 27777234Zhang F, Wagner AK, Ross-Degnan D. Simulation-based power calculation for designing interrupted time series analyses of health policy interventions. J Clin Epidemiol. 2011 Nov;64(11):1252-61. doi: 10.1016/j.jclinepi.2011.02.007.
PubMed 21640554
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Computed Tomographic Angiography to Optimize the Diagnostic Yield of Invasive Angiography in Lower Risk Patients
- ClinicalTrials.gov ID
- NCT03554057
- Acronym / sponsor ID
- CarDIA / 4697
- Conditions
- Coronary Artery Disease
- Keywords
- Angiogram, Coronary Computed Tomographic Angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | – | Diagnostic Test: Coronary Computed Tomographic AngiographyAll 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. |
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- Non urgent outpatient referral
- Canadian Cardiovascular Society class I or II
- Indication for invasive angiogram includes: Rule out Coronary Artery Disease (CAD) and Cardiomyopathy
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary Computed Tomographic AngiographyAll 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 | Diagnostic test | Intervention Group |
Primary outcome
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)
4 secondary outcomes
Quantitative assessment of angiograms avoided
Time frame: Three years
Deviation from management recommendations following CCTA
Time frame: Three years
Protocol deviation as a surrogate for acceptability of the novel triage program
Time frame: Three years
Costing of new strategy
Time frame: Three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Background: PubMed 25830423Roth GA, Forouzanfar MH, Moran AE, Barber R, Nguyen G, Feigin VL, Naghavi M, Mensah GA, Murray CJ. Demographic and epidemiologic drivers of global cardiovascular mortality. N Engl J Med. 2015 Apr 2;372(14):1333-41. doi: 10.1056/NEJMoa1406656.
- Background: PubMed 18440342Sheth T, Amlani S, Ellins ML, Mehta S, Velianou J, Cappelli G, Yang S, Natarajan M. Computed tomographic coronary angiographic assessment of high-risk coronary anatomy in patients with suspected coronary artery disease and intermediate pretest probability. Am Heart J. 2008 May;155(5):918-23. doi: 10.1016/j.ahj.2007.11.035. Epub 2008 Feb 19.
- Background: PubMed 20220183Patel MR, Peterson ED, Dai D, Brennan JM, Redberg RF, Anderson HV, Brindis RG, Douglas PS. Low diagnostic yield of elective coronary angiography. N Engl J Med. 2010 Mar 11;362(10):886-95. doi: 10.1056/NEJMoa0907272.
- Background: PubMed 28545644Ouellette ML, Beller GA, Loffler AI, Workman VK, Bourque JM. Appropriate Referrals of Angiography Despite High Prevalence of Normal Coronary Arteries or Nonobstructive CAD. J Am Coll Cardiol. 2017 May 30;69(21):2673-2675. doi: 10.1016/j.jacc.2017.03.565. No abstract available.
- Background: PubMed 27777234Dewey M, Rief M, Martus P, Kendziora B, Feger S, Dreger H, Priem S, Knebel F, Bohm M, Schlattmann P, Hamm B, Schonenberger E, Laule M, Zimmermann E. Evaluation of computed tomography in patients with atypical angina or chest pain clinically referred for invasive coronary angiography: randomised controlled trial. BMJ. 2016 Oct 24;355:i5441. doi: 10.1136/bmj.i5441.
- Background: PubMed 21640554Zhang F, Wagner AK, Ross-Degnan D. Simulation-based power calculation for designing interrupted time series analyses of health policy interventions. J Clin Epidemiol. 2011 Nov;64(11):1252-61. doi: 10.1016/j.jclinepi.2011.02.007.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon-David Schwalm, MD,FRCPC,Msc principal investigator
Hamilton Health Sciences Corporation
Tej Sheth, Bsc,FRCPC,MD principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield of invasive angiography (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03554057, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.