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.
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
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
130
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.
Women's College Hospital
Toronto, Ontario, Canada
RECRUITINGTotal 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
Time frame: Through study completion, which may take up to 1 year
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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Through study completion, which may take up to 1 year
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Cumulative Radiation Dose Exposure (milliSieverts)
Total effective radiation dose from all testing modalities for each patient.
Time frame: From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months