CT Coronary Angiogram Versus Traditional Care in Emergency Department Assessment of Potential ACS
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|
|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|
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|
|Winston-Salem, NC||Wake Forest University Baptist Medical Center||no longer recruiting|
|Hershey, PA||Penn State Hershey - Milton S. Hershey Medical Center||no longer recruiting|
|Philadelphia, PA||University of Pennsylvania Health System||no longer recruiting|
|Philadelphia, PA||Penn-Presbyterian Medical Center||no longer recruiting|
|Pittsburgh, PA||University of Pittsburgh Medical Center||no longer recruiting|
|Endpoint classification||safety study|
|Intervention model||parallel assignment|
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
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
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
|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.|
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