NCT00933400

Computed Tomography Coronary Angiogram (CTCA) Versus Traditional Care in Emergency Department Assessment of Potential Acute Coronary Syndromes (ACS)

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,392 (actual)
• Sponsor: American College of Radiology · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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-triage/presentation 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 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.

Conditions

• Chest Pain
• Acute Coronary Syndrome
• Acute Myocardial Infarction
• Coronary Artery Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CT Coronary Angiography (CTCA)	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.
PROCEDURE	Traditional Strategy	Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department.

Timeline

• Start date: 2009-07-01
• Primary completion: 2012-02-01
• Completion: 2012-04-01
• First posted: 2009-07-07
• Last updated: 2024-03-06
• Results posted: 2024-03-06

Locations

5 sites across 1 country: United States