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

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Primary Purpose

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Hospital admission

About this trial

This is an interventional treatment trial for Transient Ischemic Attack (TIA) focused on measuring Transient Ischemic Attack (TIA)., Stroke., Hospital admission.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

UCSD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Admission

Discharge

Arm Description

Admission

Discharge

Outcomes

Primary Outcome Measures

modified Rankin Scale at one year.

Secondary Outcome Measures

Stroke and TIA incidence at one year

Full Information

NCT ID

NCT00304798

First Posted

March 16, 2006

Last Updated

February 3, 2015

Sponsor

University of California, San Diego

1. Study Identification

Unique Protocol Identification Number

NCT00304798

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2007

Overall Recruitment Status

Withdrawn

Study Start Date

March 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of California, San Diego

4. Oversight

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Transient Ischemic Attack (TIA), Stroke

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Admission

Arm Type

Experimental

Arm Description

Admission

Arm Title

Discharge

Arm Type

No Intervention

Arm Description

Discharge

Intervention Type

Behavioral

Intervention Name(s)

Hospital admission

Primary Outcome Measure Information:

Title

modified Rankin Scale at one year.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Stroke and TIA incidence at one year

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matt B Jensen, MD

Organizational Affiliation

UCSD Stroke Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCSD

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Transient Ischemic Attack (TIA), Stroke

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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