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出境医 / 临床实验 / Risk Evaluation and Stratification of Low Risk for Cardiovascular Disease in Women (RESOLVE)

Risk Evaluation and Stratification of Low Risk for Cardiovascular Disease in Women (RESOLVE)

Study Description
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.

Condition or disease Intervention/treatment Phase
Chest Pain Diagnostic Test: Coronary Computed Tomography Angiography (CCTA) Other: Cardiac Link Not Applicable

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
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
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.
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.

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.
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.

Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    Time interval from when family physician referral letter was sent to the cardiologist's office to appointment time to see cardiologist

  3. Hospital/ER visits [ Time Frame: Through study completion, which may take up to 1 year ]
    Number of hospital/ER visits while waiting to see cardiologist

  4. Number of Normal Invasive Diagnostic Angiograms [ Time Frame: From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months ]
    Number of invasive diagnostic angiograms done that reveal no coronary artery disease.

  5. Total Cost of Investigations [ Time Frame: Through study completion, which may take up to 1 year ]
    Total cost (in Canadian dollars) of all tests completed to reach a diagnosis for chest pain

  6. Cumulative Radiation Dose Exposure (milliSieverts) [ Time Frame: From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months ]
    Total effective radiation dose from all testing modalities for each patient.


Other Outcome Measures:
  1. Incidence of Procedure Related Adverse Events [ Time Frame: From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months ]
    Assessment of diagnostic procedure related adverse effects that may occur during the course of the trial.

  2. Incidence of Cardiovascular Events [ Time Frame: 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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).
Contacts and Locations

Contacts
Layout table for location contacts
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

Locations
Layout table for location information
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         
Sponsors and Collaborators
Elsie Nguyen
Investigators
Layout table for investigator information
Principal Investigator: Elsie T Nguyen, MD, FRCPC Women's College Hospital
Tracking Information
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
 (submitted: April 23, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • 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 ]
    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.
  • 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 ]
    Time interval from when family physician referral letter was sent to the cardiologist's office to appointment time to see cardiologist
  • Hospital/ER visits [ Time Frame: Through study completion, which may take up to 1 year ]
    Number of hospital/ER visits while waiting to see cardiologist
  • Number of Normal Invasive Diagnostic Angiograms [ Time Frame: From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months ]
    Number of invasive diagnostic angiograms done that reveal no coronary artery disease.
  • Total Cost of Investigations [ Time Frame: Through study completion, which may take up to 1 year ]
    Total cost (in Canadian dollars) of all tests completed to reach a diagnosis for chest pain
  • Cumulative Radiation Dose Exposure (milliSieverts) [ Time Frame: From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months ]
    Total effective radiation dose from all testing modalities for each patient.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 26, 2019)
  • Incidence of Procedure Related Adverse Events [ Time Frame: From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months ]
    Assessment of diagnostic procedure related adverse effects that may occur during the course of the trial.
  • Incidence of Cardiovascular Events [ Time Frame: 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
Original Other Pre-specified Outcome Measures
 (submitted: April 23, 2019)
  • Incidence of Procedure Related Adverse Events [ Time Frame: From date of randomization to date of CAD diagnosis or exclusion, assessed up to 24 months ]
    Assessment of diagnostic procedure related adverse effects that may occur during the course of the trial.
  • Incidence of Cardiovascular Events [ Time Frame: 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
  • Patient Anxiety and Experience Questionnaire [ Time Frame: Through study completion, which may take up to 1 year ]
    Assessment of patient anxiety levels and experience for different testing modalities using a patient questionnaire.
 
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.

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
Condition  ICMJE Chest Pain
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Diagnostic Test: Coronary Computed Tomography Angiography (CCTA)
    • Other: Cardiac Link
  • 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.
    Intervention: Diagnostic Test: Coronary Computed Tomography Angiography (CCTA)
  • 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.
    Interventions:
    • Diagnostic Test: Coronary Computed Tomography Angiography (CCTA)
    • Other: Cardiac Link
  • 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.
    Intervention: Diagnostic Test: Coronary Computed Tomography Angiography (CCTA)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 23, 2019)
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:

  • 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

Exclusion Criteria:

  • 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Elsie Nguyen, Women's College Hospital
Study Sponsor  ICMJE Elsie Nguyen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elsie T Nguyen, MD, FRCPC Women's College Hospital
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