Antiphospholipid Antibodies & Osteopontin as Risk Factors for Cerebrovascular Stroke in Young Adults

NCT ID: NCT03561285

Last Updated: 2020-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2020-12-01

Brief Summary

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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).

Detailed Description

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Conditions

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Stroke in Young Adults

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Stroke with antiphospholipid

antiphospholipid Abs

Intervention Type DIAGNOSTIC_TEST

Laboratory test

stroke without antiphospholipid

antiphospholipid Abs

Intervention Type DIAGNOSTIC_TEST

Laboratory test

Interventions

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antiphospholipid Abs

Laboratory test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* A study was included if it reported on the laboratory investigation of any aPL and confirmed CVE
* Included patients aged \<50 years

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Sally Samir Youssef

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eman Abbas El kady, Prof.

Role: STUDY_DIRECTOR

Investigator

Locations

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Assiut University Hospital

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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sally Samir Hussein, ass. lecturer

Role: CONTACT

01005543417

Zahraa Ibrahim Abou Eloyoun, Ass. Prof.

Role: CONTACT

01005543417

Facility Contacts

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Sally Samir Hussein, Ass. lecturer

Role: primary

01005543417

Other Identifiers

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17200187

Identifier Type: -

Identifier Source: org_study_id

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