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

Not Applicable

Completed

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

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

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-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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
CT Coronary Angiography (CTCA)[Group B]	CT Coronary Angiography (CTCA)	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.
Traditional Strategy [Group A]	Traditional Strategy	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.

Primary Outcome Measures

Name	Time	Method
Rates of Major Cardiac Events (AMI or Cardiac Death) Within 30 Days	up to 30 days of discharge from the ED	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.

Secondary Outcome Measures

Name	Time	Method
Mean Length of Hospital Stay After Initial Visit	1-7 days	Compare the length of hospital stay in hours between the groups
Health Care Utilization During the Index Hospitalization.	1-7 Days	Downstream diagnostic test during the index visit including Hospital admission or observation.
Major Adverse Cardiac Event (MACE, Including Myocardial Infarction & Cardiac Death) and Revascularization for Participants Within 1 Year Post Triage/Presentation	Through 1-yr study follow up	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
Significant Coronary Artery Disease Detected Within Index Hospitalization as Assessed by Medical Record Review.	baseline	The algorithm used for diagnosis of Significant coronary artery disease is provided in the Appendix of the protocol.
Cardiac Health Care Utilization 1 Year Post Triage/Presentation.	Through 1-yr study follow up

Locations (5): 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 Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
University of Pennsylvania Health System
🇺🇸
Philadelphia, Pennsylvania, United States