Transient Ischemic Attack (TIA) Accelerated Diagnostic Protocol

March 16, 2012 updated by: William Beaumont Hospitals

Costs and Outcomes of an Emergency Department-based Accelerated Diagnostic Protocol vs Hospitalization for Patients With Transient Ischemic Attack: a Randomized Controlled Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
length of stay, total costs, and direct costs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

William Beaumont Hospitals

Collaborators

Foundation for Education and Research in Neurological Emergencies

Investigators

  • Principal Investigator: Michael A Ross, M.D., William Beaumont Hospital, Wayne State University School of Medicine
  • Principal Investigator: Brian J O'Neil, M.D., William Beaumont Hospital, Wayne State University School of Medicine
  • Principal Investigator: Philip Kilanowski, M.D., William Beaumont Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

May 1, 2006

First Submitted That Met QC Criteria

May 1, 2006

First Posted (Estimate)

May 3, 2006

Study Record Updates

Last Update Posted (Estimate)

March 19, 2012

Last Update Submitted That Met QC Criteria

March 16, 2012

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003-020 (Other Identifier: Albert Einstein College of Medicine-IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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