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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCTA first approach with Cardiac Link | Experimental | Patient 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 | Experimental | Patient will undergo Coronary Computed Tomography Angiography as the first test, but Cardiac Link pathway will not be activated. |
|
| Usual Care with Cardiac Link | Active Comparator | 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. |
|
| Usual Care without Cardiac Link | Active Comparator | Patient will undergo the usual diagnostic test ordered by their family physician as the first test, but Cardiac Link pathway will not be activated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary Computed Tomography Angiography (CCTA) | Diagnostic Test | Cardiac imaging test that is able to detect changes is cardiac vessels and the heart. |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fahmeen J Afgani, MBBS | Contact | 1-416-323-6400 | 7319 | fahmeen.afgani@wchospital.ca |
| Elsie T Nguyen, MD, FRCPC | Contact | 1-416-340-4800 | 3291 | elsie.nguyen@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Elsie T Nguyen, MD, FRCPC | Women's College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's College Hospital | Recruiting | Toronto | Ontario | M5S1B2 | Canada |
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| ID | Term |
|---|---|
| D002637 | Chest Pain |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Cardiac Link | Other | Clinical patient flow pathway that will enable radiologist to activate expedited cardiology referral for patients who exhibit clinically significant changes during CCTA. |
|
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 |
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 |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |