Transient Ischemic Attack (TIA) Accelerated Diagnostic Protocol
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00321022|
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : March 19, 2012
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 or disease||Intervention/treatment||Phase|
|Transient Ischemic Attack||Behavioral: Accelerated Diagnostic Protocol Emergency Department Observational Unit||Not Applicable|
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 (Clinical Trial)|
|Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||August 2003|
|Study Completion Date :||September 2005|
- length of stay, total costs, and direct costs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321022
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|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|