Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03561285
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Sally Samir Youssef, Assiut University

Brief 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 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).


Condition or disease Intervention/treatment
Stroke in Young Adults Diagnostic Test: antiphospholipid Abs

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Antiphospholipid Antibodies & Osteopontin as Risk Factors for Cerebrovascular Stroke in Young Adults
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2020

Group/Cohort Intervention/treatment
Stroke with antiphospholipid Diagnostic Test: antiphospholipid Abs
Laboratory test

stroke without antiphospholipid Diagnostic Test: antiphospholipid Abs
Laboratory test




Primary Outcome Measures :
  1. Stroke patients with APs [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
stroke patients less than 50 years old
Criteria

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:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561285


Contacts
Layout table for location contacts
Contact: sally Samir Hussein, ass. lecturer 01005543417 ysailly@yahoo.com
Contact: Zahraa Ibrahim Abou Eloyoun, Ass. Prof. 01005543417 ysailly@yahoo.com

Locations
Layout table for location information
Egypt
Assiut University Hospital Recruiting
Assiut, Egypt, 71111
Contact: Sally Samir Hussein, Ass. lecturer    01005543417    ysailly@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
Layout table for investigator information
Study Director: Eman Abbas El kady, Prof. Investigator

Layout table for additonal information
Responsible Party: Sally Samir Youssef, Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03561285     History of Changes
Other Study ID Numbers: 17200187
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Antibodies, Antiphospholipid
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs