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

CCTA to Optimize the Diagnostic Yield of Invasive Angiography



Sponsors


Source

Hamilton Health Sciences Corporation

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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

Overall Status

Not yet recruiting

Start Date

2018-07-09

Completion Date

2020-01-31

Primary Completion Date

2020-01-01

Study Type

Observational

Primary Outcome

Measure

Time Frame

Diagnostic yield of invasive angiography
Three years

Secondary Outcome

Measure

Time Frame

Quantitative assessment of angiograms avoided
Three years
Deviation from management recommendations following CCTA
Three years
Protocol deviation as a surrogate for acceptability of the novel triage program
Three years
Costing of new strategy
Three years

Number Of Groups

2

Enrollment

720

Condition


Intervention

Intervention Type

Diagnostic Test

Intervention Name


Description

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

Arm Group Label

Intervention Group


Eligibility

Study Pop

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).

Sampling Method

Non-Probability Sample

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)

Gender

All

Minimum Age

18 Years

Maximum Age

75 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Jon-David Schwalm, MD,FRCPC,Msc
Principal Investigator
Hamilton Health Sciences Corporation
Tej Sheth, Bsc,FRCPC,MD
Principal Investigator
Hamilton Health Sciences Corporation

Overall Contact

Last Name

Jon-David Schwalm, MD,FRCPC,Msc

Phone

905 577 1423

Email



Verification Date

2018-05-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Keyword


Has Expanded Access

No

Condition Browse


Arm Group

Arm Group Label

Intervention Group

Description

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.


Arm Group Label

Control Group

Description

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



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Tara McCready, PhD, MBA

Phone

905 527 0271

Email



Reference

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.

PMID

25830423


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.

PMID

18440342


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.

PMID

20220183


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.

PMID

28545644


Citation

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.

PMID

27777234


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.

PMID

21640554



Acronym

CarDIA

Patient Data

Sharing Ipd

No


Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Case-Control

Time Perspective

Prospective


Study First Submitted

May 30, 2018

Study First Submitted Qc

May 30, 2018

Study First Posted

June 12, 2018

Last Update Submitted

May 30, 2018

Last Update Submitted Qc

May 30, 2018

Last Update Posted

June 12, 2018


ClinicalTrials.gov processed this data on June 12, 2018

Conditions

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Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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