Coronary Computed Tomographic Angiography in Emergency Department Chest Pain Patients at Intermediate Risk of Acute Coronary Syndrome (CCTA)
Recruitment status was Recruiting
|First Received Date ICMJE||May 15, 2007|
|Last Updated Date||November 19, 2007|
|Start Date ICMJE||November 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Emergency Department Admission Time [ Time Frame: During initial presentation to hospital ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00473863 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Coronary Computed Tomographic Angiography in Emergency Department Chest Pain Patients at Intermediate Risk of Acute Coronary Syndrome|
|Official Title ICMJE||Coronary Computed Tomographic Angiography in Emergency Department Chest Pain Patients at Intermediate Risk of Acute Coronary Syndrome|
The purpose of this study is to determine whether Coronary Computed Tomographic Angiography (CCTA) will increase patient safety by decreasing the rate of missed ACS and adverse events in patients who receive standard care plus CCTA versus standard care alone. Additional goals of the study are to determine whether CCTA can safely reduce the duration of ED visits and the number and duration of hospital admissions.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
|Intervention ICMJE||Procedure: Coronary Computed Tomographic Angiography
CCTA will be performed
|Study Arm (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||150|
|Estimated Completion Date||July 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Inclusion criteria (all of the following):
Exclusion criteria (any of the following).
|Ages||19 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Canada|
|NCT Number ICMJE||NCT00473863|
|Other Study ID Numbers ICMJE||H07-00742|
|Has Data Monitoring Committee||No|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Vancouver General Hospital|
|Collaborators ICMJE||University of British Columbia|
|Information Provided By||Vancouver General Hospital|
|Verification Date||November 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP