Ischemic StrokeNCT01487746
Presence of Minor Anti Phospholipid Antibodies in Blood Samples of Ischemic Stroke Patients and Healthy Controls
An observational study of Ischemic Stroke, run by Meir Medical Center at 1 site in Israel.
Trial summary
The investigators expect to find higher levels of both classical and minor antiphospholipid (APL) antibodies among the stroke cases. Furthermore, the investigators expect to find not only classical APLA but also minor antibodies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke
- How many people
- 207 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2011to Sep 2012
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: on a bank of 207 stroke patients serum samples, and also on 40 healthy controls. The samples were collected during the acute phase of the ischemic event.
Who may be able to join
- stroke diagnosis
- blood sampling within 36hrs from the event
- written agreement
Who cannot join
- a stroke, MI or major operation prior to the current stroke
- hypercoagulable state known in this patient
- a severe chronic disease known at the time of the stroke
- an infection on arrival (based on anamnesis, physical exam and lab tests)
- thrombolytic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Presence of Minor Anti Phospholipid Antibodies in Blood Samples of Ischemic Stroke Patients and Healthy Controls.
The investigators expect to find higher levels of both classical and minor antiphospholipid (APL) antibodies among the stroke cases. Furthermore, the investigators expect to find not only classical APLA but also minor antibodies.
The investigators believe that minor antibodies have a major role in the hypercoagulability state.
- Conditions
- Ischemic Stroke
- Keywords
- APLA, APS, Stroke, minor anti body, major anti body, APLA antibodies in Serum
- 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 |
|---|---|---|
| treatment | Stroke patients | |
| Controls | healthy controls |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionMar 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sheba Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487746
- Sponsor's protocol ID
- 0125-11-MMC
- Status last verified
- Dec 2011
- First submitted
- 5 Dec 2011
- Last updated
- 7 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presence of Minor Anti Phospholipid Antibodies in Blood Samples of Ischemic Stroke Patients and Healthy Controls.
- ClinicalTrials.gov ID
- NCT01487746
- Acronym / sponsor ID
- 0125-11-MMC
- Conditions
- Ischemic Stroke
- Keywords
- APLA, APS, Stroke, minor anti body, major anti body, APLA antibodies in Serum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Sheba Medical Center
- Study start
- Dec 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 7 Dec 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 investigators expect to find higher levels of both classical and minor antiphospholipid (APL) antibodies among the stroke cases. Furthermore, the investigators expect to find not only classical APLA but also minor antibodies.
The investigators believe that minor antibodies have a major role in the hypercoagulability state.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment | – | –Stroke patients |
| Controls | – | –healthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- on a bank of 207 stroke patients serum samples, and also on 40 healthy controls. The samples were collected during the acute phase of the ischemic event.
Key inclusion criteria (3 listed)
- stroke diagnosis
- blood sampling within 36hrs from the event
- written agreement
Key exclusion criteria (5 listed)
- a stroke, MI or major operation prior to the current stroke
- hypercoagulable state known in this patient
- a severe chronic disease known at the time of the stroke
- an infection on arrival (based on anamnesis, physical exam and lab tests)
- thrombolytic treatment
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2011.
Related trials for 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
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
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.
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 Ischemic Stroke, run by Meir Medical Center 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 3 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: status not confirmed, as of the sponsor's last update on 7 Dec 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yair Levy, Prof. (0533671735, levy.yair@clalit.org.il,), or a site near the patient. 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 7 Dec 2011.