Transient Ischemic Attack (TIA) Accelerated Diagnostic Protocol

This study has been completed.
Sponsor:
Collaborator:
Foundation for Education and Research in Neurological Emergencies
Information provided by:
William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00321022
First received: May 1, 2006
Last updated: March 16, 2012
Last verified: May 2006
  Purpose

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.


Condition Intervention
Transient Ischemic Attack
Behavioral: Accelerated Diagnostic Protocol Emergency Department Observational Unit

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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.

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • length of stay, total costs, and direct costs

Estimated Enrollment: 154
Study Start Date: August 2003
Estimated Study Completion Date: September 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321022

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00321022     History of Changes
Other Study ID Numbers: 2003-020
Study First Received: May 1, 2006
Last Updated: March 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
Transient Ischemic Attack (TIA)
Diagnostic Protocol
Observational Medicine
Emergency Department Observational Unit

Additional relevant MeSH terms:
Ischemic Attack, Transient
Ischemia
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014