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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00304798
• Other study ID #: UCSD IRB #051272
• Status: Withdrawn
• Phase: Phase 1
• First received: March 16, 2006
• Last updated: February 3, 2015
• Start date: March 2006
• Est. completion date: March 2007

Study information

• Verified date: March 2007
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack (TIA)

Intervention

Behavioral:
• Hospital admission

Locations

Country	Name	City	State
United States	UCSD	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin Scale at one year.		1 year
Secondary	Stroke and TIA incidence at one year		1 year