NCT03929341

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Elsie Nguyen · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Coronary Computed Tomography Angiography (CCTA)	Cardiac imaging test that is able to detect changes is cardiac vessels and the heart.
OTHER	Cardiac Link	Clinical patient flow pathway that will enable radiologist to activate expedited cardiology referral for patients who exhibit clinically significant changes during CCTA.

Timeline

• Start date: 2019-01-24
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2019-04-26
• Last updated: 2019-04-30

Locations

1 site across 1 country: Canada