Better Evaluation of Acute Chest Pain With Computed Tomography * a Randomized Prospective Trial
- Conditions
- Coronary artery disease10011082
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
Acute chest pain or equivalent possibly caused by coronary artery disease. Age >30 years, ability and willingness to provide informed consent.
History of significant CAD, defined as prior myocardial infarction, percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery.
Very low likelihood of an ACS, based on demographics, risk factors and
presentation (normal ECG and initial markers), without clinical requirement for observation or further investigation.
Very high-risk ACS with need for immediate coronary angiography (<90 minutes), according to clinical guidelines.
Troponins > 0.1, high risk patients who will require early invasive angiography (<48 hrs).
Clinical instability: clinical heart failure and hemodynamic instability
Contra-indications to CT: kidney failure, allergic reactions to contrast media, pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1) The proportion of patients discharged from the ED without adverse events in<br /><br>the following 30 days. Adverse events are defined as death, non-fatal<br /><br>myocardial infarction or coronary revascularisation.<br /><br><br /><br>2) The diagnostic yield is defined as the number of patients with severe<br /><br>coronary artery disease (by invasive angiography). Severe coronary artery<br /><br>disease is defined as a flow limiting or highly vulnerable plaque in one or<br /><br>more vessels, requiring revascularization according to established guidelines. </p><br>
- Secondary Outcome Measures
Name Time Method <p>a) Successful discharge rate for all adverse events (at 30 days): death,<br /><br>non-fatal MI, unstable angina, coronary revascularization, and repeat hospital<br /><br>visits for chest pain.<br /><br>b) Composite endpoint of major adverse cardiac events at 6 months: cardiac<br /><br>death, non-fatal myocardial infarction, unstable angina and repeats hospital<br /><br>visits for chest pain.<br /><br>c) Diagnosis of acute coronary syndrome (cardiovascular death, myocardial<br /><br>infarction, instable angina according to the European guidelines of<br /><br>cardiology16) at time of discharge.<br /><br>d) Late myocardial ischemia (at 2-day follow-up).<br /><br>e) Duration of hospital stay.<br /><br>f) Direct medical costs until 30th day after ED visit.<br /><br>g) Radiation exposure</p><br>