Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473863
Status:
UNKNOWN
Last Update Posted:
2007-11-20
First Post:
2007-05-15
Brief Title:
Coronary Computed Tomographic Angiography in Emergency Department Chest Pain Patients at Intermediate Risk of Acute Coronary Syndrome
Sponsor:
Vancouver General Hospital
Organization:
Vancouver General Hospital
Study Overview
Official Title:
Coronary Computed Tomographic Angiography in Emergency Department Chest Pain Patients at Intermediate Risk of Acute Coronary Syndrome
Status:
UNKNOWN
Status Verified Date:
2007-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CCTA
Brief Summary:
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
Detailed Description:
Justification
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 53 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
Objectives
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
Research Method
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
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 53 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
Objectives
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
Research Method
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None