Stroke in Young AdultsNCT03561285
Antiphospholipid Antibodies & Osteopontin as Risk Factors for Cerebrovascular Stroke in Young Adults
An observational study of Stroke in Young Adults, run by Assiut University at 1 site in Egypt.
Trial summary
The burden of stroke is increasing in many low- and middle income countries.(1) Around 10% of all thrombotic cerebrovascular events (CVE) occur in young population defined as younger than 50 years old (2) In the majority of these patients, the cause of the ischaemic stroke remains undetermined.(3) Arterial thrombosis… Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke in Young Adults
- What is being tested?
- antiphospholipid Abs
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 1 Dec 2020
- 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 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: stroke patients less than 50 years old
Who may be able to join
- A study was included if it reported on the laboratory investigation of any aPL and confirmed CVE
- Included patients aged <50 years
Who cannot join
- Exclusion criteria included non-atherosclerotic causes, rheumatic heart disease, ventricular arrhythmias, uncompensated heart failure, stroke secondary to atrial fibrillation, hematoma, brain tumors, accidental or iatrogenic stroke, arterial malformation and recent acute myocardial infarction. Information on cardiovascular and cerebrovascular risk factors will be obtained at baseline.
- Cardiovascular disease will positive if subjects reported a history of heart disease or stroke, whereas diabetes will be assessed according to fasting blood glucose and/or use of glucose-lowering drugs (including insulin).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospital
Asyut, 71111
Sally Samir Hussein, Ass. lecturer, 01005543417, ysailly@yahoo.com
About this study
The burden of stroke is increasing in many low- and middle income countries.(1) Around 10% of all thrombotic cerebrovascular events (CVE) occur in young population defined as younger than 50 years old (2)
In the majority of these patients, the cause of the ischaemic stroke remains undetermined.(3) Arterial thrombosis is a major clinical manifestation of the antiphospholipid syndrome (APS), an autoimmune condition characterised by thrombotic events and/or pregnancy morbidity with persistently positive antiphospholipid antibodies (aPL) (4).
Read more
Considering all patients with cerebral ischaemia, the prevalence of aPL seems rather high in young adults, who might constitute a subgroup at high risk for recurrence.(5)
Through the support of the Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION), a systematic review aiming to estimate the frequency of clinically significant aPL profiles in the general population (no age limit) was completed. (6)
The pathogenesis of ischemic stroke is complex, and several studies documented hypercoagulable states as a significant mechanism underlying stroke. (8).
The latter include protein C, protein S, or antithrombin III deficiencies, activated protein C resistance and anti-phospholipid antibodies (aPLA), including anticardiolipin (aCL) antibodies or lupus anticoagulant (LAC), which influence stroke susceptibility owing to their capacity to disturb normal hemostatic mechanisms (9).
While aPLA are clinically associated with a state of hypercoagulation and prothrombotic disorders, the exact mechanism underlying their prothrombotic effects remains unknown (10).
aPLA are detected either functionally, owing to their ability to prolong coagulation time in a phospholipid-dependent coagulation test (LAC), or by measuring specific [anticardiolipin (aCL) and antiphosphatidylserine (aPS)] antibodies by specific immunoassays, using anionic phospholipids as antigens (11).
The contribution of LAC to the overall risk of both venous and arterial thrombosis, including ischemic stroke, is now well recognized (12).
While the contribution of aPLA (including LAC and aCL antibodies) to thrombosis is well established, their role as independent risk factors in the pathogenesis of ischemic stroke yielded apparently conflicting results. (13).
These conflicting results could be explained by differences in ethnic origin , inherent variation in aPLA levels and in the failure in some studies to account for the contribution of covariates (14).
Osteopontin (OPN) was first identified as a protein involved in bone remodelling, but later also shown to have important immunological roles. (15).
- Conditions
- Stroke in Young Adults
- Being tested
- antiphospholipid Abs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiphospholipid AbsDiagnostic test
Laboratory test
| Study group | Role | What they receive |
|---|---|---|
| Stroke with antiphospholipid | Not described Receives: Diagnostic Test: antiphospholipid Abs | |
| stroke without antiphospholipid | Not described Receives: Diagnostic Test: antiphospholipid Abs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke patients with APs
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 posted19 Jun 2018
- Study start1 Sep 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke in Young AdultsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Samir Youssef, Assiut University
- Investigators
- Eman Abbas El kady, Prof., Study director, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561285
- Sponsor's protocol ID
- 17200187
- Status last verified
- Jul 2020
- First submitted
- 13 Apr 2018
- Last updated
- 8 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiphospholipid Antibodies & Osteopontin as Risk Factors for Cerebrovascular Stroke in Young Adults
- ClinicalTrials.gov ID
- NCT03561285
- Acronym / sponsor ID
- 17200187
- Conditions
- Stroke in Young Adults
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 19 Jun 2018 (actual)
- 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 burden of stroke is increasing in many low- and middle income countries.(1) Around 10% of all thrombotic cerebrovascular events (CVE) occur in young population defined as younger than 50 years old (2)
In the majority of these patients, the cause of the ischaemic stroke remains undetermined.(3) Arterial thrombosis is a major clinical manifestation of the antiphospholipid syndrome (APS), an autoimmune condition characterised by thrombotic events and/or pregnancy morbidity with persistently positive antiphospholipid antibodies (aPL) (4).
Considering all patients with cerebral ischaemia, the prevalence of aPL seems rather high in young adults, who might constitute a subgroup at high risk for recurrence.(5)
Through the support of the Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION), a systematic review aiming to estimate the frequency of clinically significant aPL profiles in the general population (no age limit) was completed. (6)
The pathogenesis of ischemic stroke is complex, and several studies documented hypercoagulable states as a significant mechanism underlying stroke. (8).
The latter include protein C, protein S, or antithrombin III deficiencies, activated protein C resistance and anti-phospholipid antibodies (aPLA), including anticardiolipin (aCL) antibodies or lupus anticoagulant (LAC), which influence stroke susceptibility owing to their capacity to disturb normal hemostatic mechanisms (9).
While aPLA are clinically associated with a state of hypercoagulation and prothrombotic disorders, the exact mechanism underlying their prothrombotic effects remains unknown (10).
aPLA are detected either functionally, owing to their ability to prolong coagulation time in a phospholipid-dependent coagulation test (LAC), or by measuring specific [anticardiolipin (aCL) and antiphosphatidylserine (aPS)] antibodies by specific immunoassays, using anionic phospholipids as antigens (11).
The contribution of LAC to the overall risk of both venous and arterial thrombosis, including ischemic stroke, is now well recognized (12).
While the contribution of aPLA (including LAC and aCL antibodies) to thrombosis is well established, their role as independent risk factors in the pathogenesis of ischemic stroke yielded apparently conflicting results. (13).
These conflicting results could be explained by differences in ethnic origin , inherent variation in aPLA levels and in the failure in some studies to account for the contribution of covariates (14).
Osteopontin (OPN) was first identified as a protein involved in bone remodelling, but later also shown to have important immunological roles. (15).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke with antiphospholipid | – | Diagnostic Test: antiphospholipid Abs |
| stroke without antiphospholipid | – | Diagnostic Test: antiphospholipid Abs |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- stroke patients less than 50 years old
Key inclusion criteria (2 listed)
- A study was included if it reported on the laboratory investigation of any aPL and confirmed CVE
- Included patients aged <50 years
Key exclusion criteria (2 listed)
- Exclusion criteria included non-atherosclerotic causes, rheumatic heart disease, ventricular arrhythmias, uncompensated heart failure, stroke secondary to atrial fibrillation, hematoma, brain tumors, accidental or iatrogenic stroke, arterial malformation and recent acute myocardial infarction. Information on cardiovascular and cerebrovascular risk factors will be obtained at baseline.
- Cardiovascular disease will positive if subjects reported a history of heart disease or stroke, whereas diabetes will be assessed according to fasting blood glucose and/or use of glucose-lowering drugs (including insulin).
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 |
|---|---|---|
| antiphospholipid AbsLaboratory test | Diagnostic test | Stroke with antiphospholipid, stroke without antiphospholipid |
Primary outcome
Stroke patients with APs
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
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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.
Eman Abbas El kady, Prof. study director
Investigator
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 Stroke in Young Adults, run by Assiut University at 1 site in Egypt.
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 2 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 8 Jul 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 Egypt. 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 sally Samir Hussein, ass. lecturer (01005543417, ysailly@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke patients with APs (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 8 Jul 2020.