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

February 9, 2024 updated by: American College of Radiology

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1392

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist Medical Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey - Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn-Presbyterian Medical Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional Strategy [Group A]
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.
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.
Other Names:
  • Routine Care
  • Standard of Care (SOC)
  • Traditional, Standard of Care
Experimental: CT Coronary Angiography (CTCA)[Group B]
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.
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.
Other Names:
  • CT angiography (CTA)
  • CTCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Major Cardiac Events (AMI or Cardiac Death) Within 30 Days
Time Frame: 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.
up to 30 days of discharge from the ED

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Significant Coronary Artery Disease Detected Within Index Hospitalization as Assessed by Medical Record Review.
Time Frame: baseline
The algorithm used for diagnosis of Significant coronary artery disease is provided in the Appendix of the protocol.
baseline
Mean Length of Hospital Stay After Initial Visit
Time Frame: 1-7 days
Compare the length of hospital stay in hours between the groups
1-7 days
Health Care Utilization During the Index Hospitalization.
Time Frame: 1-7 Days
Downstream diagnostic test during the index visit including Hospital admission or observation.
1-7 Days
Cardiac Health Care Utilization 1 Year Post Triage/Presentation.
Time Frame: Through 1-yr study follow up
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
Time Frame: 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
Through 1-yr study follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American College of Radiology

Collaborators

Pennsylvania Department of Health

Investigators

  • Study Chair: Harold I Litt, PhD, University of Pennsylvania Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

July 2, 2009

First Submitted That Met QC Criteria

July 2, 2009

First Posted (Estimated)

July 7, 2009

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACRIN PA 4005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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