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

Coronary Artery Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933400
• Other study ID #: ACRIN PA 4005
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: April 2012

Study information

• Verified date: February 2024
• Source: American College of Radiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1392
• Est. completion date: April 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
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	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
American College of Radiology	Pennsylvania Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 30 days of discharge from the ED
Secondary	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.	baseline
Secondary	Mean Length of Hospital Stay After Initial Visit	Compare the length of hospital stay in hours between the groups	1-7 days
Secondary	Health Care Utilization During the Index Hospitalization.	Downstream diagnostic test during the index visit including Hospital admission or observation.	1-7 Days
Secondary	Cardiac Health Care Utilization 1 Year Post Triage/Presentation.		Through 1-yr study follow up
Secondary	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	Through 1-yr study follow up

External Links

•   Click here for more information about this study: ACRIN PA 4005, CT Coronary Angiography Versus Traditional Care for Low-Risk ED Patients With ACS.