Status:
COMPLETED
Computed Tomography Coronary Angiogram (CTCA) Versus Traditional Care in Emergency Department Assessment of Potential Acute Coronary Syndromes (ACS)
Lead Sponsor:
American College of Radiology
Collaborating Sponsors:
Pennsylvania Department of Health
Conditions:
Chest Pain
Acute Coronary Syndrome
Eligibility:
All Genders
30+ years
Phase:
NA
Brief 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 in...
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 v...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
1392 Patients enrolled
Trial Details
Trial ID
NCT00933400
Start Date
July 1 2009
End Date
April 1 2012
Last Update
March 6 2024
Active Locations (5)
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1
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
2
Penn State Hershey - Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
3
Penn-Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
4
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104