Coronary Computed Tomographic Angiography in Emergency Department Chest Pain Patients at Intermediate Risk of Acute Coronary Syndrome (CCTA)
Recruitment status was: Recruiting
|Acute Coronary Syndrome Acute Myocardial Infarction Unstable Angina Coronary Disease Coronary Stenosis||Procedure: Coronary Computed Tomographic Angiography||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Coronary Computed Tomographic Angiography in Emergency Department Chest Pain Patients at Intermediate Risk of Acute Coronary Syndrome|
- Emergency Department Admission Time [ Time Frame: During initial presentation to hospital ]
- CCU consult time [ Time Frame: During initial presentation to hospital ]
- CCU decision time [ Time Frame: During initial presentation to hospital ]
- Duration of CCU admission [ Time Frame: During initial presentation to hospital ]
- Adverse event rate [ Time Frame: 30 days post ED visit ]
- All-cause mortality [ Time Frame: 30 days post-ED visit ]
|Study Start Date:||November 2007|
|Estimated Study Completion Date:||July 2008|
Procedure: Coronary Computed Tomographic Angiography
CCTA will be performed
|No Intervention: Control|
Acute coronary syndrome (ACS) is the clinical manifestation of acute myocardial ischemia induced by coronary artery disease (CAD). Although most patients presenting with chest pain to the Emergency Department (ED) can be stratified into "high risk" or "low risk" chest pain algorithms, patients at "intermediate risk" are more difficult to manage. This translates into lengthy waits in the ED and repetitive investigations while 5.3% of cases of ACS are still missed and too many patients are admitted to the CCU (false positive rate of 14%). CCTA is a novel, non-invasive method for evaluating coronary artery stenosis and occlusion.
The ability to accurately diagnose or exclude ACS in patients in a rapid, non-invasive fashion has been previously lacking. If CCTA is shown to be clinically useful in risk stratification of this patient population, there is great potential for increasing patient safety, reducing ED admission times and decreasing the number and duration of CCU admission.
ED admission and discharge times, CCU consult and decision times and duration of CCU admission, cardiac risk factors, vital signs, laboratory results, ED disposition plan, CCTA results, coronary calcium score, index hospitalization diagnosis, investigations, revascularization rates as well as 30-day diagnosis, death, adverse event rate and subsequent investigations.
The study population will consist of ED chest pain patients at intermediate risk of ACS. Informed consent will be obtained for both CCTA and the 30-day follow up. Patients will be randomized into one of two diagnostic arms: standard care plus CCTA versus standard care alone. If the patient receives CCTA, the test will be interpreted by a blinded radiologist and the results provided to the ED physician and entered into the patient chart. A research nurse will collect workflow and clinical data for all enrolled patients.
Two reviewers, an ED physician and a cardiologist, blinded to the CCTA results, will independently review the index and 30 day clinical data. One of the following will be assigned: acute myocardial infarction, definite unstable angina, possible unstable angina, or no acute coronary syndrome. Alternate non-ACS diagnoses will be ascertained when applicable.
Statistical Analysis This proposal represents a pilot study to demonstrate the feasibility of identifying and recruiting patients to the trial, demonstrate the feasibility of collecting follow-up data, and provide preliminary estimates of outcome measures to help determine the sample size required for a definitive study. All analyses will be descriptive. Recruitment, crossover, follow-up, and completion rates will be determined. Estimates of diagnostic accuracy and length of stay in the ED will be determined and will be used to inform the design of the definitive study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00473863
|Contact: William F Dick, MD||604 875 email@example.com|
|Canada, British Columbia|
|Vancouver, British Columbia, Canada, V5Z1M9|
|Contact: William Dick, MD 604 875 4700 firstname.lastname@example.org|
|Sub-Investigator: James KH Woo, MD BSc|
|Sub-Investigator: Savvas Nicolaou, MD|
|Sub-Investigator: Doug McKnight, MD|
|Sub-Investigator: John Mayo, MD|
|Principal Investigator:||William F Dick, MD||Vancouver General Hospital|
|Study Director:||John Mayo, MD||Vancouver General Hospital|