Overview

This trial is active, not recruiting.

Conditions chest pain, acute coronary syndrome, acute myocardial infarction, coronary artery disease
Treatments ct coronary angiography, traditional, standard of care
Phase phase 4
Sponsor American College of Radiology Imaging Network
Collaborator Pennsylvania Department of Health
Start date July 2009
End date February 2012
Trial size 1365 participants
Trial identifier NCT00933400, ACRIN PA 4005

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Active Comparator)
In the traditional-care arm (Group A), 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.
traditional, standard of care
Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department.
(Experimental)
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.
ct coronary angiography
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.

Primary Outcomes

Measure
To estimate the rate of major cardiac events (AMI or cardiac death) within 30 days in 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.
time frame: Within 30 days of discharge from the ED

Secondary Outcomes

Measure
To estimate and compare the rates of significant CAD detected within the index visit in participants across the two study arms.
time frame: 1-7 days, 30 days, and 1 year
To compare hospital length of stay across the two study groups.
time frame: 1-7 days
To compare health care utilization and cost incurred by participants in the two study groups during the index hospitalization.
time frame: 1-7 Days
To compare cardiac health care utilization and cost incurred by participants in the two study groups during 1 year post triage/presentation.
time frame: Through 1-yr study follow up
To compare rates of major cardiac events (cardiac death, AMI, and revascularization for participants who were not found to have significant CAD at the index visit) among participants in the two study groups within 1 year post triage/presentation.
time frame: Through 1-yr study follow up

Eligibility Criteria

Male or female participants at least 30 years old.

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

Additional Information

Official title Randomized Controlled Study of a Rapid "Rule Out" Strategy Using CT Coronary Angiogram Versus Traditional Care for Low- to Intermediate-Risk ED Patients With Potential Acute Coronary Syndromes
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by American College of Radiology Imaging Network.