Ignite Creation Date:
2024-05-06 @ 1:04 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03929341
Status:
UNKNOWN
Last Update Posted:
2019-04-30
First Post:
2019-01-15
Brief Title:
Risk Evaluation and Stratification of Low Risk for Cardiovascular Disease in Women
Sponsor:
Elsie Nguyen
Organization:
Womens College Hospital
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESOLVE
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 Womens 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 ie CCTA to sort out whether or not CAD is responsible for their chest pain will increase thereby decreasing over-investigation of low risk women
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 Womens 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None