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Study of Admission Versus Discharge After Transient Ischemic Attack (TIA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by University of California, San Diego.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00304798
First received: March 16, 2006
Last updated: March 30, 2007
Last verified: March 2007
History of Changes
  Purpose

Evaluate for difference in outcome between hospital admission versus discharge after recent TIA, and evaluate feasibility of a larger study.


Condition Intervention Phase
Transient Ischemic Attack (TIA)
Stroke
 Behavioral: Hospital admission
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Admission Versus Discharge After Transient Ischemic Attack (TIA)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • modified Rankin Scale at one year.

Secondary Outcome Measures:
  • Stroke and TIA incidence at one year, amount and cost of tests, adverse events.

Estimated Enrollment: 20
Study Start Date: March 2006
Estimated Study Completion Date: March 2007
Detailed Description:

20 patients will be randomized within 24 hours of a TIA to be admitted to the hospital or discharged to home, and we will compare outcomes, cost, and evaluate the feasibility of a larger study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 and older.
  • Clinical diagnosis of TIA within 24 hours of consent.

Exclusion Criteria:

  • Crescendo TIAs, defined as multiple within 24 hours of presentation.
  • Posterior circulation TIAs diagnosed clinically by a member of the Stroke Team.
  • High grade carotid stenosis.
  • Any compelling medical reason they should or should not be admitted or discharged (for example decompensated congestive heart failure, unstable angina, new EKG changes, pneumonia, sepsis). Patients will only be enrolled if the only consideration for admission is the TIA, and they otherwise meet appropriate standard of care criteria for discharge to home.
  • Patients will be excluded if no one can be with them for the next 12 hours to ensure a rapid call to 911 should problems arise, specifically stroke.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304798

Locations
United States, California
UCSD
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Matt B Jensen, MD UCSD Stroke Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00304798     History of Changes
Other Study ID Numbers: UCSD IRB #051272
Study First Received: March 16, 2006
Last Updated: March 30, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Transient Ischemic Attack (TIA).
Stroke.
Hospital admission.

Additional relevant MeSH terms:
Ischemic Attack, Transient
Ischemia
Stroke
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 May 16, 2013