N/A
N=1,392
Computed Tomography Coronary Angiogram (CTCA) Versus Traditional Care in Emergency Department Assessment of Potential Acute Coronary Syndromes (ACS)
Chest Pain · Acute Coronary Syndrome · Acute Myocardial Infarction · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT00933400 ↗Enrolled (actual)
1,392
Serious AEs
0.1%
Results posted
Mar 2024
Primary outcome: Primary: Rates of Major Cardiac Events (AMI or Cardiac Death) Within 30 Days — 0; 0; 0; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CT Coronary Angiography (CTCA) (Diagnostic_test); Traditional Strategy (Procedure)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- American College of Radiology
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rates of Major Cardiac Events (AMI or Cardiac Death) Within 30 Days |
0; 0; 0; 10; 5; 0 | — |
| SECONDARY Significant Coronary Artery Disease Detected Within Index Hospitalization as Assessed by Medical Record Review. |
450; 105; 458; 357; 82; 16 | — |
| SECONDARY Mean Length of Hospital Stay After Initial Visit |
18.0; 24.8; 12.3; 24.7 | — |
| SECONDARY Health Care Utilization During the Index Hospitalization. |
767; 26; 124; 267; 37; 18 | — |
| SECONDARY Cardiac Health Care Utilization 1 Year Post Triage/Presentation. |
305; 166; 137; 74; 148; 53 | — |
| SECONDARY Major Adverse Cardiac Event (MACE, Including Myocardial Infarction & Cardiac Death) and Revascularization for Participants Within 1 Year Post Triage/Presentation |
2; 3; 1; 0; 11; 5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00933400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.