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Transient Ischemic Attack (TIA) Accelerated Diagnostic Protocol

Primary Purpose

Transient Ischemic Attack

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Accelerated Diagnostic Protocol Emergency Department Observational Unit
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Transient Ischemic Attack focused on measuring Transient Ischemic Attack (TIA), Diagnostic Protocol, Observational Medicine, Emergency Department Observational Unit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Transient ischemic attack confirmed by emergency physician - resolved deficit, not a crescendo TIA. Negative HCT Exclusion Criteria: Positive HCT scan for bleed, mass, acute infarct Possible embolic source - A. fib, paroxysmal.A.fib, cardiomyopathy, artificial heart valve, endocarditis, patent foramen ovale, recent MI Known carotid stenosis (>50%) or mural thrombus Persistent acute neurological deficits Crescendo TIAs Non-focal symptoms - ie confusion, weakness, seizure, transient global amnesia Hypertensive encephalophy / emergency Severe headache or evidence of cranial arteritis Fever Previous stroke Severe dementia Nursing home patient Social issues that make discharge or follow up unlikely Other acute medical problems requiring inpatient admission Patient unlikely to survive beyond study follow up period (90 days) History of IV drug use

Sites / Locations

  • William Beaumont Hospital

Outcomes

Primary Outcome Measures

length of stay, total costs, and direct costs

Secondary Outcome Measures

Full Information

First Posted
May 1, 2006
Last Updated
March 16, 2012
Sponsor
William Beaumont Hospitals
Collaborators
Foundation for Education and Research in Neurological Emergencies
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1. Study Identification

Unique Protocol Identification Number
NCT00321022
Brief Title
Transient Ischemic Attack (TIA) Accelerated Diagnostic Protocol
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
William Beaumont Hospitals
Collaborators
Foundation for Education and Research in Neurological Emergencies

4. Oversight

5. Study Description

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.
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 300,000 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, 10.5% 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, 2.6% of TIA patients will die, 2.6% will suffer other adverse cardiovascular events, and 12.7% 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, U.S. dept of health and human services). The national direct and indirect cost of stroke is estimated to be $51 billion annually.7 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Ischemic Attack
Keywords
Transient Ischemic Attack (TIA), Diagnostic Protocol, Observational Medicine, Emergency Department Observational Unit

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Accelerated Diagnostic Protocol Emergency Department Observational Unit
Primary Outcome Measure Information:
Title
length of stay, total costs, and direct costs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Transient ischemic attack confirmed by emergency physician - resolved deficit, not a crescendo TIA. Negative HCT Exclusion Criteria: Positive HCT scan for bleed, mass, acute infarct Possible embolic source - A. fib, paroxysmal.A.fib, cardiomyopathy, artificial heart valve, endocarditis, patent foramen ovale, recent MI Known carotid stenosis (>50%) or mural thrombus Persistent acute neurological deficits Crescendo TIAs Non-focal symptoms - ie confusion, weakness, seizure, transient global amnesia Hypertensive encephalophy / emergency Severe headache or evidence of cranial arteritis Fever Previous stroke Severe dementia Nursing home patient Social issues that make discharge or follow up unlikely Other acute medical problems requiring inpatient admission Patient unlikely to survive beyond study follow up period (90 days) History of IV drug use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Ross, M.D.
Organizational Affiliation
William Beaumont Hospital, Wayne State University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian J O'Neil, M.D.
Organizational Affiliation
William Beaumont Hospital, Wayne State University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philip Kilanowski, M.D.
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States

12. IPD Sharing Statement

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Transient Ischemic Attack (TIA) Accelerated Diagnostic Protocol

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