Chest PainRESOLVENCT03929341
Risk Evaluation and Stratification of Low Risk for Cardiovascular Disease in Women
A study testing Coronary Computed Tomography Angiography (CCTA) and Cardiac Link in people with Chest Pain, run by Elsie Nguyen at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chest Pain
- What is being tested?
- Coronary Computed Tomography Angiography (CCTA) and Cardiac Link
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jan 2019to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Women's College Hospital
Toronto, Ontario, M5S1B2
Fahmeen J Afgani, MBBS, 416-323-6400 ext. 7319, fahmeen.afgani@wchospital.ca
Paula J Harvey, BMBS
About this study
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
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.
Read the 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.
- Conditions
- Chest Pain
- Being tested
- Coronary Computed Tomography Angiography (CCTA), Cardiac Link
- Keywords
- angina
- Medical subject headings
- Chest Pain, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Computed Tomography Angiography (CCTA)Diagnostic test
Cardiac imaging test that is able to detect changes is cardiac vessels and the heart.
Cardiac LinkOther
Clinical patient flow pathway that will enable radiologist to activate expedited cardiology referral for patients who exhibit clinically significant changes during CCTA.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Coronary Computed Tomography Angiography (CCTA); Other: Cardiac Link |
| 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. Receives: Diagnostic Test: Coronary Computed Tomography Angiography (CCTA) |
| 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. Receives: Diagnostic Test: Coronary Computed Tomography Angiography (CCTA); Other: Cardiac Link |
| 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. Receives: Diagnostic Test: Coronary Computed Tomography Angiography (CCTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, which may take up to 1 year
Secondary outcomes (6)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start24 Jan 2019
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsie Nguyen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elsie Nguyen, Women's College Hospital
- Investigators
- Elsie T Nguyen, MD, FRCPC, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929341
- Sponsor's protocol ID
- 2014-0069-B
- Acronym
- RESOLVE
- Status last verified
- Apr 2019
- First submitted
- 15 Jan 2019
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03929341
- Acronym / sponsor ID
- RESOLVE / 2014-0069-B
- Conditions
- Chest Pain
- Keywords
- angina
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Elsie NguyenUniversity, hospital or other
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 26 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CCTA first approach with Cardiac Link | Experimental | Diagnostic Test: Coronary Computed Tomography Angiography (CCTA), Other: Cardiac LinkPatient 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 | Diagnostic Test: Coronary Computed Tomography Angiography (CCTA)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 | Diagnostic Test: Coronary Computed Tomography Angiography (CCTA), Other: Cardiac LinkPatient 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 | Diagnostic Test: Coronary Computed Tomography Angiography (CCTA)Patient will undergo the usual diagnostic test ordered by their family physician as the first test, but Cardiac Link pathway will not be activated. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary Computed Tomography Angiography (CCTA)Cardiac imaging test that is able to detect changes is cardiac vessels and the heart. | Diagnostic test | CCTA first approach with Cardiac Link, CCTA first approach without Cardiac Link, Usual Care with Cardiac Link, Usual Care without Cardiac Link |
| Cardiac LinkClinical patient flow pathway that will enable radiologist to activate expedited cardiology referral for patients who exhibit clinically significant changes during CCTA. | Other | CCTA first approach with Cardiac Link, Usual Care with Cardiac Link |
Primary outcome
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
6 secondary outcomes
Time to Diagnosis
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 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
Time frame: Through study completion, which may take up to 1 year
Number of Normal Invasive Diagnostic Angiograms
Time frame: From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months
Total Cost of Investigations
Time frame: Through study completion, which may take up to 1 year
Cumulative Radiation Dose Exposure (milliSieverts)
Time frame: From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elsie T Nguyen, MD, FRCPC principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Computed Tomography Angiography (CCTA) and Cardiac Link in people with Chest Pain, run by Elsie Nguyen at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fahmeen J Afgani, MBBS (1-416-323-6400 ext. 7319, fahmeen.afgani@wchospital.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Tests (time frame: Through study completion, which may take up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.