Transient Ischemic Attack (TIA)Phase 1NCT00304798
Study of Admission Versus Discharge After Transient Ischemic Attack (TIA)
A Phase 1 study testing Hospital admission in people with Transient Ischemic Attack (TIA) and Stroke, run by University of California, San Diego at 1 site in United States.
Trial summary
Evaluate for difference in outcome between hospital admission versus discharge after recent TIA, and evaluate feasibility of a larger study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transient Ischemic Attack (TIA), Stroke
- What is being tested?
- Hospital admission
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Mar 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and older.
- Clinical diagnosis of TIA within 24 hours of consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Admission Versus Discharge After Transient Ischemic Attack (TIA)
Evaluate for difference in outcome between hospital admission versus discharge after recent TIA, and evaluate feasibility of a larger study.
Read the 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.
- Conditions
- Transient Ischemic Attack (TIA), Stroke
- Being tested
- Hospital admission
- Keywords
- Transient Ischemic Attack (TIA)., Stroke., Hospital admission.
- Medical subject headings
- Ischemic Attack, Transient, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital admissionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Admission | Experimental | Admission Receives: Behavioral: Hospital admission |
| Discharge | No intervention | Discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Scale at one year.
Measured: 1 year
Secondary outcomes (1)
Stroke and TIA incidence at one year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2006 (estimated)
- Study startMar 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Ischemic Attack (TIA)Studies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Investigators
- Matt B Jensen, MD, Principal investigator, UCSD Stroke Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304798
- Sponsor's protocol ID
- UCSD IRB #051272
- Status last verified
- Mar 2007
- First submitted
- 16 Mar 2006
- Last updated
- 4 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Admission Versus Discharge After Transient Ischemic Attack (TIA)
- ClinicalTrials.gov ID
- NCT00304798
- Acronym / sponsor ID
- UCSD IRB #051272
- Conditions
- Transient Ischemic Attack (TIA), Stroke
- Keywords
- Transient Ischemic Attack (TIA)., Stroke., Hospital admission.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 20 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Admission | Experimental | Behavioral: Hospital admissionAdmission |
| Discharge | No intervention | –Discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 and older.
- Clinical diagnosis of TIA within 24 hours of consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hospital admission | Behavioural | Admission |
Primary outcome
modified Rankin Scale at one year.
Time frame: 1 year
1 secondary outcome
Stroke and TIA incidence at one year
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matt B Jensen, MD principal investigator
UCSD Stroke Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hospital admission in people with Transient Ischemic Attack (TIA) and Stroke, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale at one year. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.