Condition or disease | Intervention/treatment | Phase |
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Chest Pain | Diagnostic Test: Coronary Computed Tomography Angiography (CCTA) Other: Cardiac Link | Not Applicable |
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 (Clinical Trial) |
Estimated Enrollment : | 130 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | 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 |
Actual Study Start Date : | January 24, 2019 |
Estimated Primary Completion Date : | January 2021 |
Estimated Study Completion Date : | January 2021 |
Arm | Intervention/treatment |
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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.
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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.
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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.
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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.
|
Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Fahmeen J Afgani, MBBS | 1-416-323-6400 ext 7319 | fahmeen.afgani@wchospital.ca | |
Contact: Elsie T Nguyen, MD, FRCPC | 1-416-340-4800 ext 3291 | elsie.nguyen@uhn.ca |
Canada, Ontario | |
Women's College Hospital | Recruiting |
Toronto, Ontario, Canada, M5S1B2 | |
Contact: Fahmeen J Afgani, MBBS 416-323-6400 ext 7319 fahmeen.afgani@wchospital.ca | |
Principal Investigator: Paula J Harvey, BMBS | |
Sub-Investigator: Deborah Levitan, MD |
Principal Investigator: | Elsie T Nguyen, MD, FRCPC | Women's College Hospital |
Tracking Information | |||||
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First Submitted Date ICMJE | January 15, 2019 | ||||
First Posted Date ICMJE | April 26, 2019 | ||||
Last Update Posted Date | April 30, 2019 | ||||
Actual Study Start Date ICMJE | January 24, 2019 | ||||
Estimated Primary Completion Date | January 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Total Number of Tests [ Time Frame: Through study completion, which may take up to 1 year ] The total number of tests a patient has to complete in order to diagnose the cause of their chest pain or equivalent symptoms
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures |
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Descriptive Information | |||||
Brief Title ICMJE | Risk Evaluation and Stratification of Low Risk for Cardiovascular Disease in Women | ||||
Official Title ICMJE | 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 | ||||
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. | ||||
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Chest Pain | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
130 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | January 2021 | ||||
Estimated Primary Completion Date | January 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Canada | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03929341 | ||||
Other Study ID Numbers ICMJE | 2014-0069-B | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Elsie Nguyen, Women's College Hospital | ||||
Study Sponsor ICMJE | Elsie Nguyen | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Women's College Hospital | ||||
Verification Date | April 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |