Ignite Creation Date:
2024-05-05 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 9:49 AM
Study NCT ID:
NCT00678639
Status:
COMPLETED
Last Update Posted:
2018-09-11
First Post:
2008-05-08
Brief Title:
Cost Comparison of Cardiac Magnetic Resonance Imaging MRI Use in Emergency Department ED Patients With Chest Pain
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Randomized Cost Comparison of Cardiac MRI Use in ED Patients With Chest Pain
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
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:
None
Brief Summary:
The purpose of this study is to investigate the best way to evaluate patients with chest pain in the emergency department It compares receiving treatment in an observation unit with admission to the hospital Patients treated in the observation unit will undergo cardiac Magnetic Resonance Imaging MRI testing Patients treated with hospital admission will undergo the testing their doctor determines is best for them All patients will undergo follow up to find out if they have had any heart related events
Detailed Description:
Almost half of patients presenting to the Emergency Department ED with possible cardiac chest pain are at intermediate risk for short term death or infarction Most are admitted to the hospital for serial ECGs cardiac biomarkers cardiology consultation and stress testing or coronary angiogram However the 2007 ACCAHA guidelines suggest that these patients can be managed in an observation unit OU Recently cardiac magnetic resonance imaging CMR has proven more accurate than traditional testing modalities for the diagnosis of acute coronary syndrome ACS and has also received endorsement from the American College of Cardiology ACCAmerican Heart Association AHA guidelines Immediate application of CMR in an OU may improve health care utilization compared to standard hospital admission for intermediate risk patients
Research hypotheses
1 Patients in an OU CMR protocol will have lower cost for the index hospitalization than standard care
2 An OU CMR protocol for patients with intermediate risk chest pain will significantly improve the frequency of correct cardiovascular admission decisions when compared to standard care
Methods summary
110 ED patients at intermediate risk for short-term death or infarction with nondiagnostic Electrocardiograms ECG and normal initial cardiac biomarkers will be randomized to standard care or OU CMR protocols Subjects in the OU CMR protocol will undergo CMR perfusion and stress testing followed by serial biomarkers Standard care subjects will be admitted for usual cardiac testing ACS infarction death coronary revascularization unstable angina will be assessed by evaluation of hospital course and phone follow-up at 30 days Cost of hospital care will be compared among groups
Research hypotheses
1 Patients in an OU CMR protocol will have lower cost for the index hospitalization than standard care
2 An OU CMR protocol for patients with intermediate risk chest pain will significantly improve the frequency of correct cardiovascular admission decisions when compared to standard care
Methods summary
110 ED patients at intermediate risk for short-term death or infarction with nondiagnostic Electrocardiograms ECG and normal initial cardiac biomarkers will be randomized to standard care or OU CMR protocols Subjects in the OU CMR protocol will undergo CMR perfusion and stress testing followed by serial biomarkers Standard care subjects will be admitted for usual cardiac testing ACS infarction death coronary revascularization unstable angina will be assessed by evaluation of hospital course and phone follow-up at 30 days Cost of hospital care will be compared among groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None