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-triage/presentation major cardiac event rates.
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 1:2 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 triage/presentation. 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 triage/presentation. Participants with positive test results will be admitted to the hospital for further management dictated by the admitting team.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,392
CT coronary angiography will be performed without and with contrast in participants randomized to receive imaging as well as traditional care. (For applicable purposes, the decision to perform contrast-enhanced imaging in the presence of a large amount of calcium should be made according to procedures at each individual site.) The imaging test will be considered positive if the participant has a greater than 50% stenosis of the right coronary, left main, left anterior descending, or circumflex arteries or of their branches in contrast-enhanced CT coronary angiography. Results will be communicated to the responsible ED and treating staff immediately upon interpretation; ED staff will determine appropriate course of management. Negative results will result in patient discharge.
Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department.
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Penn State Hershey - Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Penn-Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Rates of Major Cardiac Events (AMI or Cardiac Death) Within 30 Days
To estimate the rate of major cardiac events (AMI or cardiac death) within 30 days of discharge from Emergency Department (ED) - patient follow-up included telephone interviews 30 days and 1 year after triage/presentation. Participants in Group B who were found not to have stenosis of the main or first order coronary branches greater than or equal to 50% by CT coronary angiography were considered negative and considered discharged if they were not designated to receive an inpatient bed or formal observation status. All myocardial infarctions were reviewed by an Adjudication Committee to confirm diagnosis.
Time frame: up to 30 days of discharge from the ED
Significant Coronary Artery Disease Detected Within Index Hospitalization as Assessed by Medical Record Review.
The algorithm used for diagnosis of Significant coronary artery disease is provided in the Appendix of the protocol.
Time frame: baseline
Mean Length of Hospital Stay After Initial Visit
Compare the length of hospital stay in hours between the groups
Time frame: 1-7 days
Health Care Utilization During the Index Hospitalization.
Downstream diagnostic test during the index visit including Hospital admission or observation.
Time frame: 1-7 Days
Cardiac Health Care Utilization 1 Year Post Triage/Presentation.
Time frame: Through 1-yr study follow up
Major Adverse Cardiac Event (MACE, Including Myocardial Infarction & Cardiac Death) and Revascularization for Participants Within 1 Year Post Triage/Presentation
MACE at 1 year was determined by Patient telephone contact Medical record review Records at the presenting and neighboring hospitals were reviewed for repeat visits When these methods failed to provide survival information, we searched the Social Security Death Master File
Time frame: Through 1-yr study follow up
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