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Completed

NCT Number: NCT00933400

Computed Tomography Coronary Angiogram (CTCA) Versus Traditional Care in Emergency Department Assessment of 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.

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Key information

Conditions

Chest Pain Acute Coronary Syndrome Acute Myocardial Infarction Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Disease Attributes Emergencies Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT Coronary Angiography (CTCA)

Diagnostic Test

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

Traditional Strategy

Procedure

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: Standard of Care (SOC), Traditional, Standard of Care, Routine Care

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Mean Length of Hospital Stay After Initial Visit

    Time frame: 1-7 days

    Compare the length of hospital stay in hours between the groups

  3. Health Care Utilization During the Index Hospitalization.

    Time frame: 1-7 Days

    Downstream diagnostic test during the index visit including Hospital admission or observation.

  4. Cardiac Health Care Utilization 1 Year Post Triage/Presentation.

    Time frame: Through 1-yr study follow up

  5. 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

Sponsors and collaborators

Lead sponsor

American College of Radiology

Other

Collaborators

  • Pennsylvania Department of Health

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 7, 2009
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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