Risk Evaluation and Stratification of Low Risk for Cardiovascular Disease in Women
RESOLVE
1 other identifier
interventional
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2019
CompletedStudy Start
First participant enrolled
January 24, 2019
CompletedFirst Posted
Study publicly available on registry
April 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedApril 30, 2019
April 1, 2019
1.9 years
January 15, 2019
April 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Time to Diagnosis
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
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
Through study completion, which may take up to 1 year
Number of Normal Invasive Diagnostic Angiograms
From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months
Total Cost of Investigations
Through study completion, which may take up to 1 year
- +1 more secondary outcomes
Other Outcomes (2)
Incidence of Procedure Related Adverse Events
From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months
Incidence of Cardiovascular Events
From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months
Study Arms (4)
CCTA first approach with Cardiac Link
EXPERIMENTALPatient will undergo Coronary Computed Tomography Angiography as the first test and have Cardiac Link pathway activated for expedited cardiology referral.
CCTA first approach without Cardiac Link
EXPERIMENTALPatient will undergo Coronary Computed Tomography Angiography as the first test, but Cardiac Link pathway will not be activated.
Usual Care with Cardiac Link
ACTIVE COMPARATORPatient 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.
Usual Care without Cardiac Link
ACTIVE COMPARATORPatient will undergo the usual diagnostic test ordered by their family physician as the first test, but Cardiac Link pathway will not be activated.
Interventions
Cardiac imaging test that is able to detect changes is cardiac vessels and the heart.
Clinical patient flow pathway that will enable radiologist to activate expedited cardiology referral for patients who exhibit clinically significant changes during CCTA.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elsie Nguyenlead
Study Sites (1)
Women's College Hospital
Toronto, Ontario, M5S1B2, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elsie T Nguyen, MD, FRCPC
Women's College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Radiology
Study Record Dates
First Submitted
January 15, 2019
First Posted
April 26, 2019
Study Start
January 24, 2019
Primary Completion
January 1, 2021
Study Completion
January 1, 2021
Last Updated
April 30, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share