Clinical trial NCT03929341: Risk Evaluation and Stratification of Low Risk for Cardiovascular Disease in Women
Official title: Risk Evaluation and Stratification of Low Risk for Cardiovascular Disease in Women: An Innovative Strategy for Investigating Stable Chest Pain in Low to Intermediate Risk Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chest Pain
Keywords: angina
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 130
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed description: Coronary artery disease (CAD) is the leading cause of death in women globally. Women are more likely to present with atypical chest pain that may be difficult to diagnose using traditional testing methods, resulting in over-investigation.

Coronary computed tomography angiography (CCTA) has high negative predictive value for exclusion of CAD in low to intermediate risk populations. We plan to investigate CCTA as a first line test to exclude coronary artery disease as a cause of stable chest pain and whether it is a cost effective strategy that reduces time to diagnosis, wait times to see cardiologists, emergency department visits, downstream and repeat testing and radiation exposure as compared to usual care with comparable patient safety and satisfaction level.

Another intervention being tested in this trial is the Cardiac Link pathway. This is a new clinical program at Women's College Hospital that aims to expedite cardiology referral for patients exhibiting clinically significant findings while undergoing CCTAs.

We hope that with use of CCTA as the first test, the number of women who require only one test (i.e. CCTA) to sort out whether or not CAD is responsible for their chest pain will increase, thereby decreasing over-investigation of low risk women.

Eligibility criteria: 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).

Primary outcomes:
measure: Total Number of Tests
timeFrame: Through study completion, which may take up to 1 year
Secondary outcomes:
measure: Time to Diagnosis
timeFrame: From date of first presentation with chest pain to date of CAD diagnosis or exclusion, assessed up to 24 months
measure: Wait Times to See a Cardiologist
timeFrame: From date of cardiology referral letter sent by family physician to date of cardiologist appointment with patient, assessed up to 24 months
measure: Hospital/ER visits
timeFrame: Through study completion, which may take up to 1 year
measure: Number of Normal Invasive Diagnostic Angiograms
timeFrame: From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months
measure: Total Cost of Investigations
timeFrame: Through study completion, which may take up to 1 year
measure: Cumulative Radiation Dose Exposure (milliSieverts)
timeFrame: From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months
Other outcomes:
measure: Incidence of Procedure Related Adverse Events
timeFrame: From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months
measure: Incidence of Cardiovascular Events
timeFrame: From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Elsie T Nguyen, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: