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

American College of Radiology (ACR)

Status: Completed

Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Chest Pain; Acute Myocardial Infarction

Treatments: Procedure: Traditional Strategy; Diagnostic Test: CT Coronary Angiography (CTCA)

Study type: Interventional

Funder types: Other

Identifiers

NCT00933400

ACRIN PA 4005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,392 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant is 30 years of age or older
• Participant presents with complaints consistent with potential ACS (e.g., chest pain, shortness of breath, other)
• Participant requires admission or objective testing to exclude ACS
• Participant with initial ECG result without acute ischemia
• Participant with an initial Thrombolysis in Myocardial Infarction (TIMI) Risk Score of 0 to 2
• Participant is willing to provide a written informed consent

Exclusion criteria

• Patients who present with symptoms that are clearly not cardiac in origin (e.g., chest pain secondary to herpes zoster, obvious pneumonia, or recent trauma);
• Patients with no initial ECG performed in the ED
• Patients with ST-elevation myocardial infarction (STEMI)
• Patients with existing co-morbidity that requires admission regardless of presence of ACS (e.g., uncontrolled diabetes)
• Patients with known contraindications to CT coronary angiography: Iodinated contrast allergic-like reaction
• Patients who are known to have had CT coronary angiography in the year prior to presentation
• Patients who are known to have normal catheterization results (no or minimal, < 25%, stenosis) in the year prior to presentation
• Patients who are pregnant
• Patients with known renal insufficiency (e.g., creatinine clearance < 60 mL/min/1.73 m2)
• Patients with no telephone or cell phone numbers (preventing follow up)
• Patients unwilling to provide a written informed consent

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,392 participants in 2 patient groups

Traditional Strategy [Group A]

Active Comparator group

Description:

In the traditional-care arm (Group A:Standard of Care (SOC)), all management and disposition decisions will be made by the healthcare providers caring for the participant. Participants will receive disposition (admit to hospital, admit to cardiac diagnostic unit, or discharge to home), diagnostic testing (none, stress testing, or cardiac catheterization), and treatment according to the team caring for the participant.

Treatment:

Procedure: Traditional Strategy

CT Coronary Angiography (CTCA)[Group B]

Experimental group

Description:

In the study CT coronary angiography-based rapid "rule out" arm (Group B), participants will receive initial cardiac troponin and creatinine tests. Upon return of normal laboratory values (including a calculated creatinine clearance), the participants will receive a CT coronary angiography an estimated 90 minutes or as soon as the CT scanner is available following the initial values assessment. Participants with negative test results will be discharged unless other indications for admission per standard of care and follow up will comprise telephone interviews 30 days and 1 year after triage/presentation. Participants with positive test results will be admitted to the hospital for further management as dictated by the admitting team.

Treatment:

Diagnostic Test: CT Coronary Angiography (CTCA)