Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321022
Status:
COMPLETED
Last Update Posted:
2012-03-19
First Post:
2006-05-01
Brief Title:
Transient Ischemic Attack TIA Accelerated Diagnostic Protocol
Sponsor:
William Beaumont Hospitals
Organization:
William Beaumont Hospitals
Study Overview
Official Title:
Costs and Outcomes of an Emergency Department-based Accelerated Diagnostic Protocol vs Hospitalization for Patients With Transient Ischemic Attack a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2006-05
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 primary objective of this study is to determine if emergency department patients with Transient Ischemic Attack TIA that are managed using a TIA accelerated diagnostic protocol or ADP demonstrate a significant decrease in their index visit length of stay and cost with comparable diagnostic and 90-day clinical outcomes relative to TIA patients randomized to traditional inpatient care
The secondary objectives are to evaluate the potential role of a TIA risk stratification tool and to determine the time to a diagnostic endpoint in both groups
The secondary objectives are to evaluate the potential role of a TIA risk stratification tool and to determine the time to a diagnostic endpoint in both groups
Detailed Description:
Transient ischemic attack TIA is defined as a neurological deficit lasting less than 24 hours with most lasting less than one hour brought on by focal cerebral or retinal ischemia TIAs are common with an estimated 300000 events occurring annually and an estimated 5 million Americans having been given the diagnosis of TIA Furthermore a TIA is essentially the smoke before the fire for these patients Studies have shown that within 90 days of an emergency department diagnosis of TIA 105 of patients will suffer a stroke with most occurring within two days of the ED visit Twenty one percent of these strokes are fatal and 64 are disabling Additionally 26 of TIA patients will die 26 will suffer other adverse cardiovascular events and 127 will have recurrent TIAs Roughly 15 of patients who have had a stroke report a history of TIA For many patients stroke is considered to be a devastating event that is worse than death In 1999 stroke was the third leading cause of death in the United States National center for health statistics US dept of health and human services The national direct and indirect cost of stroke is estimated to be 51 billion annually7
The management and disposition of emergency department patients with TIA is not entirely clear It is mutually agreed upon in guidelines written by the American Heart Association AHA and the National Stroke Association NSA for the management of TIA and standard emergency medicine textbooks that patients with symptoms suggestive of a stroke or TIA require urgent evaluation in a setting such as the emergency department Furthermore that this evaluation should include a history physical and ECG AHA guidelines and emergency medicine texts recommend that the initial evaluation include appropriate blood testing based on the history and CT imaging of the brain All agree that patients with noncardioembolic causes of TIA should receive antiplatelet therapy and that TIA patients with atrial fibrillation should receive anticoagulation Prompt or Urgent imaging of the carotid arteries to detect stenosis greater than 70 is also agreed upon since urgent carotid endarterectomy is believed to be most beneficial in this group However the optimal timing of endarterectomy in patients with high-grade carotid stenosis is unclear NSA guidelines and emergency medicine texts recommend hospitalization of patients with new onset TIA if imaging studies such as carotid doppler can not be performed urgently However in a separate review of TIA management hospitalization was identified as an area of uncertainty and it was suggested that management in a setting such as an Emergency Department Observation Unit EDOU might be a more cost effective alternative
The management and disposition of emergency department patients with TIA is not entirely clear It is mutually agreed upon in guidelines written by the American Heart Association AHA and the National Stroke Association NSA for the management of TIA and standard emergency medicine textbooks that patients with symptoms suggestive of a stroke or TIA require urgent evaluation in a setting such as the emergency department Furthermore that this evaluation should include a history physical and ECG AHA guidelines and emergency medicine texts recommend that the initial evaluation include appropriate blood testing based on the history and CT imaging of the brain All agree that patients with noncardioembolic causes of TIA should receive antiplatelet therapy and that TIA patients with atrial fibrillation should receive anticoagulation Prompt or Urgent imaging of the carotid arteries to detect stenosis greater than 70 is also agreed upon since urgent carotid endarterectomy is believed to be most beneficial in this group However the optimal timing of endarterectomy in patients with high-grade carotid stenosis is unclear NSA guidelines and emergency medicine texts recommend hospitalization of patients with new onset TIA if imaging studies such as carotid doppler can not be performed urgently However in a separate review of TIA management hospitalization was identified as an area of uncertainty and it was suggested that management in a setting such as an Emergency Department Observation Unit EDOU might be a more cost effective alternative
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