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Risk Evaluation and Stratification of Low Risk for Cardiovascular Disease in Women (RESOLVE Trial)
N/A
Waitlist Available
Led By Elsie T Nguyen, MD, FRCPC
Research Sponsored by Elsie Nguyen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, which may take up to 1 year
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Chest Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, which may take up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, which may take up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Total Number of Tests
Secondary study objectives
Cumulative Radiation Dose Exposure (milliSieverts)
Hospital/ER visits
Number of Normal Invasive Diagnostic Angiograms
+3 moreOther study objectives
Incidence of Cardiovascular Events
Incidence of Procedure Related Adverse Events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: CCTA first approach without Cardiac LinkExperimental Treatment1 Intervention
Patient will undergo Coronary Computed Tomography Angiography as the first test, but Cardiac Link pathway will not be activated.
Group II: CCTA first approach with Cardiac LinkExperimental Treatment2 Interventions
Patient will undergo Coronary Computed Tomography Angiography as the first test and have Cardiac Link pathway activated for expedited cardiology referral.
Group III: Usual Care with Cardiac LinkActive Control2 Interventions
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 IV: Usual Care without Cardiac LinkActive Control1 Intervention
Patient will undergo the usual diagnostic test ordered by their family physician as the first test, but Cardiac Link pathway will not be activated.
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Who is running the clinical trial?
Elsie NguyenLead Sponsor
Elsie T Nguyen, MD, FRCPCPrincipal InvestigatorWomen's College Hospital