Risk Evaluation and Stratification of Low Risk for Cardiovascular Disease in Women (RESOLVE)

Elsie Nguyen

Status: Unknown

Conditions: Chest Pain

Treatments: Diagnostic Test: Coronary Computed Tomography Angiography (CCTA); Other: Cardiac Link

Study type: Interventional

Funder types: Other

Identifiers

NCT03929341

2014-0069-B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

130 participants in 4 patient groups

CCTA first approach with Cardiac Link

Experimental group

Description:

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

Treatment:

Other: Cardiac Link

Diagnostic Test: Coronary Computed Tomography Angiography (CCTA)

CCTA first approach without Cardiac Link

Experimental group

Description:

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

Treatment:

Diagnostic Test: Coronary Computed Tomography Angiography (CCTA)

Usual Care with Cardiac Link

Active Comparator group

Description:

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.

Treatment:

Other: Cardiac Link

Diagnostic Test: Coronary Computed Tomography Angiography (CCTA)

Usual Care without Cardiac Link

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Coronary Computed Tomography Angiography (CCTA)