CT Coronary Angiogram Versus Traditional Care in Emergency Department Assessment of Potential ACS
|ClinicalTrials.gov Identifier: NCT00933400|
Recruitment Status : Unknown
Verified March 2012 by American College of Radiology Imaging Network.
Recruitment status was: Active, not recruiting
First Posted : July 7, 2009
Last Update Posted : March 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Chest Pain Acute Coronary Syndrome Acute Myocardial Infarction Coronary Artery Disease||Procedure: CT Coronary Angiography Procedure: Traditional, Standard of Care||Phase 4|
In this study, participants with potential ACS will be randomized to traditional "rule out" care (Group A) or to traditional care plus CT coronary angiography (Group B) in a ratio of 1:2 traditional versus traditional plus CT coronary angiography.
In Group A, all management and disposition decisions will be made by the healthcare providers caring for the participant. Participants will be admitted to hospital, admitted to cardiac diagnostic unit, or discharged to home. Diagnostic testing and treatment will be decided by the team caring for the participant. Follow up will comprise telephone interviews after 30 days and 1 year from triage/presentation.
In Group B, participants will receive initial cardiac troponin and creatinine blood tests. Upon return of normal laboratory values, the participants will receive a CT coronary angiography an estimated 90 minutes after the initial values assessment or as soon as the CT scanner is available. Participants with negative test results will be discharged; follow up will comprise telephone interviews after 30 days and 1 year from triage/presentation. Participants with positive test results will be admitted to the hospital for further management dictated by the admitting team.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1365 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Study of a Rapid "Rule Out" Strategy Using CT Coronary Angiogram Versus Traditional Care for Low- to Intermediate-Risk ED Patients With Potential Acute Coronary Syndromes|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||February 2012|
|Estimated Study Completion Date :||April 2012|
Active Comparator: Traditional Strategy (Group A)
In the traditional-care arm (Group A), all management and disposition decisions will be made by the healthcare providers caring for the participant. Participants will receive disposition (admit to hospital, admit to cardiac diagnostic unit, or discharge to home), diagnostic testing (none, stress testing, or cardiac catheterization), and treatment according to the team caring for the participant.
Procedure: Traditional, Standard of Care
Participants randomized to traditional care will be assessed and discharged/treated according to routine standard-of-care procedures in the institution's emergency department.
Experimental: CT Coronary Angiography (Group B)
In the study CT coronary angiography-based rapid "rule out" arm (Group B), participants will receive initial cardiac troponin and creatinine tests. Upon return of normal laboratory values (including a calculated creatinine clearance), the participants will receive a CT coronary angiography an estimated 90 minutes or as soon as the CT scanner is available following the initial values assessment. Participants with negative test results will be discharged unless other indications for admission per standard of care and follow up will comprise telephone interviews 30 days and 1 year after triage/presentation. Participants with positive test results will be admitted to the hospital for further management as dictated by the admitting team.
Procedure: CT Coronary Angiography
CT coronary angiography will be performed without and with contrast in participants randomized to receive imaging as well as traditional care. (For applicable purposes, the decision to perform contrast-enhanced imaging in the presence of a large amount of calcium should be made according to procedures at each individual site.) The imaging test will be considered positive if the participant has a greater than 50% stenosis of the right coronary, left main, left anterior descending, or circumflex arteries or of their branches in contrast-enhanced CT coronary angiography. Results will be communicated to the responsible ED and treating staff immediately upon interpretation; ED staff will determine appropriate course of management. Negative results will result in patient discharge.
- To estimate the rate of major cardiac events (AMI or cardiac death) within 30 days in participants in Group B who were found not to have stenosis of the main or first order coronary branches greater than or equal to 50% by CT coronary angiography. [ Time Frame: Within 30 days of discharge from the ED ]
- To estimate and compare the rates of significant CAD detected within the index visit in participants across the two study arms. [ Time Frame: 1-7 days, 30 days, and 1 year ]
- To compare hospital length of stay across the two study groups. [ Time Frame: 1-7 days ]
- To compare health care utilization and cost incurred by participants in the two study groups during the index hospitalization. [ Time Frame: 1-7 Days ]
- To compare cardiac health care utilization and cost incurred by participants in the two study groups during 1 year post triage/presentation. [ Time Frame: Through 1-yr study follow up ]
- To compare rates of major cardiac events (cardiac death, AMI, and revascularization for participants who were not found to have significant CAD at the index visit) among participants in the two study groups within 1 year post triage/presentation. [ Time Frame: Through 1-yr study follow up ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933400
|United States, North Carolina|
|Wake Forest University Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Pennsylvania|
|Penn State Hershey - Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Penn-Presbyterian Medical Center|
|Philadelphia, Pennsylvania, United States, 19104|
|University of Pennsylvania Health System|
|Philadelphia, Pennsylvania, United States, 19104|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Study Chair:||Harold I Litt, PhD||University of Pennsylvania Health System|