Risk Evaluation and Stratification of Low Risk for Cardiovascular Disease in Women

NCT ID: NCT03929341

Last Updated: 2019-04-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-24
• Study Completion Date: 2021-01-31

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.

Conditions

Chest Pain

Keywords

angina

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Coronary Computed Tomography Angiography (CCTA)

Intervention Type: DIAGNOSTIC_TEST

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

Cardiac Link

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Coronary Computed Tomography Angiography (CCTA)

Intervention Type: DIAGNOSTIC_TEST

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

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.

Group Type: ACTIVE_COMPARATOR

Coronary Computed Tomography Angiography (CCTA)

Intervention Type: DIAGNOSTIC_TEST

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

Cardiac Link

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Coronary Computed Tomography Angiography (CCTA)

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Coronary Computed Tomography Angiography (CCTA)

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

Intervention Type: DIAGNOSTIC_TEST

Cardiac Link

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

Intervention Type: OTHER

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).

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elsie Nguyen

OTHER

Sponsor Role: lead

Responsible Party

Elsie Nguyen

Associate Professor of Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Elsie T Nguyen, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Locations

Women's College Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Fahmeen J Afgani, MBBS

Role: CONTACT

Phone: 1-416-323-6400

Email: fahmeen.afgani@wchospital.ca

Elsie T Nguyen, MD, FRCPC

Role: CONTACT

Phone: 1-416-340-4800

Email: elsie.nguyen@uhn.ca

Facility Contacts

Fahmeen J Afgani, MBBS

Role: primary

Other Identifiers

2014-0069-B

Identifier Type: -

Identifier Source: org_study_id