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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1392 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Rapid Assessment of Potential Ischaemic Heart Disease With CTCA

NCT02284191

Acute Coronary Syndrome

COMPLETED NA

Coronary Computed Tomographic Angiography in Intermediate-risk Chest Pain Patients

NCT04748237

Chest Pain Acute Coronary Syndrome Coronary Artery Disease

RECRUITING NA

Coronary Computed Tomographic Angiography in Emergency Department Chest Pain Patients at Intermediate Risk of Acute Coronary Syndrome

NCT00473863

Acute Coronary Syndrome Acute Myocardial Infarction Unstable Angina +2 more

UNKNOWN PHASE3

Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography

NCT01084239

Acute Coronary Syndrome Myocardial Infarction Unstable Angina Pectoris

COMPLETED PHASE3

Pilot Safety Study of Coronary CTA for the Diagnosis of Acute Coronary Syndrome in the Emergency Room

NCT01682096

Acute Coronary Syndrome Coronary Artery Disease Cardiac Death +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chest Pain Acute Coronary Syndrome Acute Myocardial Infarction Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Traditional Strategy

Intervention Type 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.

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.

Group Type EXPERIMENTAL

CT Coronary Angiography (CTCA)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CT angiography (CTA) CTCA Standard of Care (SOC) Traditional, Standard of Care Routine Care

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No