Ignite Creation Date:
2024-05-05 @ 9:19 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00869245
Status:
COMPLETED
Last Update Posted:
2017-11-08
First Post:
2009-03-24
Brief Title:
Efficacy Evaluation of Observation Unit Cardiac Magnetic Resonance Imaging MRI in Patients With Intermediate Risk Acute Chest Pain
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Efficacy Evaluation of Observation Unit Cardiac Magnetic Resonance Imaging MRI in Patients With Intermediate Risk Acute Chest Pain
Status:
COMPLETED
Status Verified Date:
2017-04
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 types of cardiac tests performed while receiving treatment in an observation unit Patients will either undergo cardiac MRI testing or conventional care testing Patients treated in the conventional care testing group 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:
Despite spending 12 billion annually on the emergency evaluation of chest pain in the US only 15 of admitted patients have a cardiac cause of their presenting symptoms Observation units OU improve resource utilization are endorsed by the ACCAHA guidelines but have seen limited implementation in non-low risk chest pain patients due to limitations of traditional cardiac testing Cardiac magnetic resonance imaging CMR is sensitive and specific for ischemia can simultaneously assess cardiac function and myocardial perfusion and could revolutionize the diagnostic process for intermediate risk patients with chest pain The superior accuracy of CMR could decrease testing resulting from false positive results The high sensitivity for ongoing ischemia could allow imaging in parallel with cardiac markers
Research hypotheses
OU-CMR will have superior therapeutic efficacy to OU-conventional testing
An OU-CMR strategy will have higher diagnostic thinking efficacy than OU-conventional testing
Methods summary
To address the question of feasibility of a CMR approach to managing patients at intermediate risk for ACS we propose a randomized clinical trial of 120 patients at intermediate risk of ACS that present to the ED of Wake Forest University Baptist Medical Center WFUBMC for evaluation of chest pain All patients will receive care in an OU and will be randomized to CMR or conventional testing CMR participants will undergo cardiac markers and CMR testing conventional testing participants will undergo serial cardiac markers followed by conventional 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
OU-CMR will have superior therapeutic efficacy to OU-conventional testing
An OU-CMR strategy will have higher diagnostic thinking efficacy than OU-conventional testing
Methods summary
To address the question of feasibility of a CMR approach to managing patients at intermediate risk for ACS we propose a randomized clinical trial of 120 patients at intermediate risk of ACS that present to the ED of Wake Forest University Baptist Medical Center WFUBMC for evaluation of chest pain All patients will receive care in an OU and will be randomized to CMR or conventional testing CMR participants will undergo cardiac markers and CMR testing conventional testing participants will undergo serial cardiac markers followed by conventional 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?:
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AHA Identification 0980008N | None | None | None |