Acute Ischemic StrokeNCT01323413
Determinants of Penumbra in Acute Ischemic Stroke Patients
An observational study of Acute Ischemic Stroke, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The purpose of the study is to examine the influence of demographic, clinical and laboratory characteristics on the presence and size of penumbra in acute ischemic stroke patients and to determine those of them which related significantly and independently to the presence and size of Penumbra. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Ischemic Stroke
- How many people
- 250 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2011to Dec 2016
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: neurological ward
Who may be able to join
- Acute ischemic stroke patients hospitalized in Rambam Health Care Campus between 2008-2010, and which have underwent neurological evaluation including NIHSS scale, Brain CT, CT angio and Ct perfusion.
Who cannot join
- Intracranial hemorrhage of any other brain condition
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to examine the influence of demographic, clinical and laboratory characteristics on the presence and size of penumbra in acute ischemic stroke patients and to determine those of them which related significantly and independently to the presence and size of Penumbra. The examined factors will include demographic variables such as age, gender, ethnic background, vascular risk factors and medical history, clinical parameters such as time from stroke onset until arrival to the hospital, results of neurological evaluation by NIHSS and imaging findings, laboratory tests such as body temperature, blood pressure, glucose level, renal functions etc. and imaging findings - the presence and the size of collateral blood vessels, the state of carotid arteries (by CTA). The possible correlation between all this parameters and the presence and the size of penumbra as detected by CTP will be further examined.
- Conditions
- Acute Ischemic Stroke
- Keywords
- stroke, penumbra, determinants, CT perfusion
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| stroke | acute ischemic stroke patients |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rambam62, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323413
- Sponsor's protocol ID
- 0080-11CTIL
- Status last verified
- Jun 2020
- First submitted
- 24 Mar 2011
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Penumbra in Acute Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT01323413
- Acronym / sponsor ID
- 0080-11CTIL
- Conditions
- Acute Ischemic Stroke
- Keywords
- stroke, penumbra, determinants, CT perfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Mar 2011 (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.
The purpose of the study is to examine the influence of demographic, clinical and laboratory characteristics on the presence and size of penumbra in acute ischemic stroke patients and to determine those of them which related significantly and independently to the presence and size of Penumbra. The examined factors will include demographic variables such as age, gender, ethnic background, vascular risk factors and medical history, clinical parameters such as time from stroke onset until arrival to the hospital, results of neurological evaluation by NIHSS and imaging findings, laboratory tests such as body temperature, blood pressure, glucose level, renal functions etc. and imaging findings - the presence and the size of collateral blood vessels, the state of carotid arteries (by CTA). The possible correlation between all this parameters and the presence and the size of penumbra as detected by CTP will be further examined.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stroke | – | –acute ischemic stroke patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- neurological ward
Key inclusion criteria (1 listed)
- Acute ischemic stroke patients hospitalized in Rambam Health Care Campus between 2008-2010, and which have underwent neurological evaluation including NIHSS scale, Brain CT, CT angio and Ct perfusion.
Key exclusion criteria (1 listed)
- Intracranial hemorrhage of any other brain condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Rambam Health Care Campus at 1 site in Israel.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Jun 2020. 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 Israel. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 12 Jun 2020.