Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Presence of Minor Anti Phospholipid Antibodies in Blood Samples of Ischemic Stroke Patients and Healthy Controls

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Meir Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Sheba Medical Center
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01487746
First received: December 5, 2011
Last updated: December 6, 2011
Last verified: December 2011
  Purpose

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.


Condition
Ischemic Stroke

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Presence of Minor Anti Phospholipid Antibodies in Blood Samples of Ischemic Stroke Patients and Healthy Controls.

Further study details as provided by Meir Medical Center:

Biospecimen Retention:   Samples Without DNA

Serum samples of Stroke patients withdrawned within 36 hrs since stroke evoked. Healthy controls


Estimated Enrollment: 207
Study Start Date: December 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
treatment
Stroke patients
Controls
healthy controls

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • stroke diagnosis
  • blood sampling within 36hrs from the event
  • written agreement

Exclusion Criteria:

  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487746

Contacts
Contact: Yair Levy, Prof. 0533671735 levy.yair@clalit.org.il,
Contact: Narin N Carmel, B.Sc 0547691482 carmeln@gmail.com

Locations
Israel
Meir health center Not yet recruiting
Kfar-saba, Israel
Sponsors and Collaborators
Meir Medical Center
Sheba Medical Center
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01487746     History of Changes
Other Study ID Numbers: 0125-11-MMC
Study First Received: December 5, 2011
Last Updated: December 6, 2011
Health Authority: Israel: Clalit Health Services

Keywords provided by Meir Medical Center:
APLA
APS
Stroke
minor anti body
major anti body
APLA antibodies in Serum

Additional relevant MeSH terms:
Cerebral Infarction
Ischemia
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Antibodies
Antibodies, Antiphospholipid
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014