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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chest Pain
• Intervention / Treatment: Diagnostic test: Coronary Computed Tomography Angiography (CCTA); Other: Cardiac Link

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.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S1B2
      • Recruiting
      • Women's College Hospital
      • Principal Investigator: Paula J Harvey, BMBS
      • Sub-Investigator: Deborah Levitan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	Diagnostic test: Coronary Computed Tomography Angiography (CCTA); Cardiac imaging test that is able to detect changes is cardiac vessels and the heart.
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.	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.
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.	Diagnostic test: Coronary Computed Tomography Angiography (CCTA); Cardiac imaging test that is able to detect changes is cardiac vessels and the heart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Tests	The total number of tests a patient has to complete in order to diagnose the cause of their chest pain or equivalent symptoms	Through study completion, which may take up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Diagnosis	Time interval from time of presentation to family physician for evaluation of chest pain to the last test performed to determine etiology of chest pain or CAD exclusion.	From date of first presentation with chest pain to date of CAD diagnosis or exclusion, assessed up to 24 months
Wait Times to See a Cardiologist	Time interval from when family physician referral letter was sent to the cardiologist's office to appointment time to see cardiologist	From date of cardiology referral letter sent by family physician to date of cardiologist appointment with patient, assessed up to 24 months
Hospital/ER visits	Number of hospital/ER visits while waiting to see cardiologist	Through study completion, which may take up to 1 year
Number of Normal Invasive Diagnostic Angiograms	Number of invasive diagnostic angiograms done that reveal no coronary artery disease.	From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months
Total Cost of Investigations	Total cost (in Canadian dollars) of all tests completed to reach a diagnosis for chest pain	Through study completion, which may take up to 1 year
Cumulative Radiation Dose Exposure (milliSieverts)	Total effective radiation dose from all testing modalities for each patient.	From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Procedure Related Adverse Events	Assessment of diagnostic procedure related adverse effects that may occur during the course of the trial.	From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months
Incidence of Cardiovascular Events	Assessment of cardiovascular events that may take place during the course of the study, while waiting for a diagnosis for the cause of chest pain	From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months

Collaborators and Investigators

• Sponsor: Elsie Nguyen
• Investigators: Principal Investigator: Elsie T Nguyen, MD, FRCPC, Women's College Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 24, 2019
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): January 1, 2021

Study Registration Dates

• First Submitted: January 15, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (ACTUAL): April 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 26, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: angina
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cardiovascular Diseases; Chest Pain
• Other Study ID Numbers: 2014-0069-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No