NCT00304798

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2006

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

February 4, 2015

Status Verified

March 1, 2007

First QC Date

March 16, 2006

Last Update Submit

February 3, 2015

Conditions

Transient Ischemic Attack (TIA)Stroke

Keywords

Transient Ischemic Attack (TIA).Stroke.Hospital admission.

Outcome Measures

Primary Outcomes (1)

  • modified Rankin Scale at one year.

    1 year

Secondary Outcomes (1)

  • Stroke and TIA incidence at one year

    1 year

Study Arms (2)

Admission

EXPERIMENTAL

Admission

Behavioral: Hospital admission

Discharge

NO INTERVENTION

Discharge

Interventions

Hospital admissionBEHAVIORAL
Admission

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Ischemic Attack, TransientStroke

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Matt B Jensen, MD

    UCSD Stroke Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 16, 2006

First Posted

March 20, 2006

Study Start

March 1, 2006

Study Completion

March 1, 2007

Last Updated

February 4, 2015

Record last verified: 2007-03

Locations

US(1)