CCTA to Optimize the Diagnostic Yield of Invasive Angiography

Coronary Artery Disease Clinical Trial

— CarDIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03554057
• Other study ID #: 4697
• Status: Completed
• Start date: July 9, 2018
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2022
• Source: Hamilton Health Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: March 1, 2022
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Hamilton Academic Health Sciences Organization

Country where clinical trial is conducted

Canada, 

References & Publications (6)

Dewey M, Rief M, Martus P, Kendziora B, Feger S, Dreger H, Priem S, Knebel F, Böhm M, Schlattmann P, Hamm B, Schönenberger 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. Erratum in: BMJ. 2016 Nov 29;355:i6420. — View Citation

Ouellette ML, Beller GA, Löffler 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. — View Citation

Patel 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. Erratum in: N Engl J Med. 2010 Jul 29;363(5):498. — View Citation

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. — View Citation

Sheth 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. — View Citation

Zhang 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Three years
Secondary	Quantitative assessment of angiograms avoided	Number of angiograms avoided due to CCTA bookings	Three years
Secondary	Deviation from management recommendations following CCTA	Number of angiograms performed when not recommended	Three years
Secondary	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	Three years
Secondary	Costing of new strategy	Cost of risk stratification of Coronary Artery Disease in low risk patients	Three years