Ignite Creation Date:
2024-05-05 @ 9:38 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00933400
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2009-07-02
Brief Title:
Computed Tomography Coronary Angiogram CTCA Versus Traditional Care in Emergency Department Assessment of Potential Acute Coronary Syndromes ACS
Sponsor:
American College of Radiology
Organization:
American College of Radiology
Study Overview
Official Title:
Randomized Controlled Study of a Rapid Rule Out Strategy Using Computed Tomography Coronary Angiogram CTCA Versus Traditional Care for Low- to Intermediate-Risk Emergency Department ED Patients With Potential Acute Coronary Syndromes ACS
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
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:
None
Brief Summary:
This multi-center randomized controlled trial conducted in Emergency Departments ED compares computed tomography CT coronary angiography with the traditional approach usual care for low- to intermediate-risk chest pain patients The primary objective is to estimate the rate of major cardiac events heart attack or cardiac death within 30 days in trial participants in Group B who were not found to have significant coronary artery disease by CT coronary angiography Additional evaluations will comprise health care utilization assessments including length of hospital stay and re-admissions cost analysis and 1-year post-triagepresentation major cardiac event rates
Detailed Description:
In this study participants with potential ACS will be randomized to traditional rule out care Group A or to traditional care plus CT coronary angiography Group B in a ratio of 12 traditional versus traditional plus CT coronary angiography
In Group A all management and disposition decisions will be made by the healthcare providers caring for the participant Participants will be admitted to hospital admitted to cardiac diagnostic unit or discharged to home Diagnostic testing and treatment will be decided by the team caring for the participant Follow up will comprise telephone interviews after 30 days and 1 year from triagepresentation
In Group B participants will receive initial cardiac troponin and creatinine blood tests Upon return of normal laboratory values the participants will receive a CT coronary angiography an estimated 90 minutes after the initial values assessment or as soon as the CT scanner is available Participants with negative test results will be discharged follow up will comprise telephone interviews after 30 days and 1 year from triagepresentation Participants with positive test results will be admitted to the hospital for further management dictated by the admitting team
In Group A all management and disposition decisions will be made by the healthcare providers caring for the participant Participants will be admitted to hospital admitted to cardiac diagnostic unit or discharged to home Diagnostic testing and treatment will be decided by the team caring for the participant Follow up will comprise telephone interviews after 30 days and 1 year from triagepresentation
In Group B participants will receive initial cardiac troponin and creatinine blood tests Upon return of normal laboratory values the participants will receive a CT coronary angiography an estimated 90 minutes after the initial values assessment or as soon as the CT scanner is available Participants with negative test results will be discharged follow up will comprise telephone interviews after 30 days and 1 year from triagepresentation Participants with positive test results will be admitted to the hospital for further management dictated by the admitting team
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None