Recruiting

Observational Study

Sponsor:

Elsie Nguyen

Code:

NCT03929341

Conditions

Chest Pain

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Coronary Computed Tomography Angiography (CCTA)

Cardiac Link

Study Details

Brief summary:

This study will evaluate the ability of Coronary Computed Tomography Angiography (CCTA), used as a first-line diagnostic tool in women with stable chest pain and low risk for Coronary Artery Disease (CAD), to reduce the number of women requiring more than one diagnostic test to rule in or rule out CAD. Half of the participants will undergo CCTA as the first test to investigate stable chest pain, while the other half will undergo any test ordered by their family physician.

Conditions

Chest Pain

Study ID

NCT03929341

Start date

Jan 24, 2019

Status verified date

Apr, 2019

Completion date

Jan, 2021

Anticipated

Primary completion date

Jan, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Men and women age ≥ 40 years of age
  • Stable chest pain or equivalent symptoms
  • Planned non-urgent, non-invasive testing for diagnosis of chest pain or equivalent symptoms

Exclusion Criteria:

  • Acute coronary syndrome, including acute myocardial infarction or unstable angina, known non-ischemic cardiomyopathy or other cardiac disease (e.g. mitral valve prolapse, etc.) which would require urgent cardiac evaluation
  • Known CAD
  • Prior cardiac evaluation for current episode of symptoms
  • Previously investigated for CAD in the last 12 months
  • Severe allergic reaction to iodinated contrast (mild reactions such as urticaria that can be controlled by premedication with Benadryl \& Prednisone may be included in the study)
  • Renal failure or dysfunction (estimated Glomerular Filtration Rate<30ml/min/m2 within the past 3 months)
  • Pregnancy (status will be confirmed verbally. For premenopausal patients who are unsure, status will be confirmed by completing a pregnancy strip test).

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: CCTA first approach with Cardiac Link

Patient will undergo Coronary Computed Tomography Angiography as the first test and have Cardiac Link pathway activated for expedited cardiology referral.

experimental: CCTA first approach without Cardiac Link

Patient will undergo Coronary Computed Tomography Angiography as the first test, but Cardiac Link pathway will not be activated.

active comparator: Usual Care with Cardiac Link

Patient will undergo the usual diagnostic test ordered by their family physician as the first test, and have Cardiac Link pathway activated for expedited cardiology referral.

active comparator: Usual Care without Cardiac Link

Patient will undergo the usual diagnostic test ordered by their family physician as the first test, but Cardiac Link pathway will not be activated.

Interventions

Coronary Computed Tomography Angiography (CCTA)

Cardiac imaging test that is able to detect changes is cardiac vessels and the heart.

Cardiac Link

Clinical patient flow pathway that will enable radiologist to activate expedited cardiology referral for patients who exhibit clinically significant changes during CCTA.

Primary outcome measure

  • Total Number of Tests [ Time Frame: Through study completion, which may take up to 1 year ]

Central Contacts and Locations

Central contacts

Fahmeen J Afgani, MBBS

1-416-323-6400fahmeen.afgani@wchospital.ca

Elsie T Nguyen, MD, FRCPC

1-416-340-4800elsie.nguyen@uhn.ca

Locations

Women's College Hospital

Recruiting

Toronto, Ontario, Canada, M5S1B2

Contacts

Fahmeen J Afgani, MBBS

416-323-6400fahmeen.afgani@wchospital.ca

Principal Investigator:

Paula J Harvey, BMBS

More Information

Sponsor

Elsie Nguyen

Last update posted

Apr 30, 2019

Last verified

Apr, 2019

Keywords

  • angina

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Elsie Nguyen on 2019-04-30.