Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03929341
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Elsie Nguyen, Women's College Hospital

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.


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929341


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

Layout table for additonal information
Responsible Party: Elsie Nguyen, Associate Professor of Radiology, Women's College Hospital
ClinicalTrials.gov Identifier: NCT03929341     History of Changes
Other Study ID Numbers: 2014-0069-B
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elsie Nguyen, Women's College Hospital:
angina

Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms