NCT01487746

Brief 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. The investigators believe that minor antibodies have a major role in the hypercoagulability state.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

December 7, 2011

Status Verified

December 1, 2011

Enrollment Period

3 months

First QC Date

December 5, 2011

Last Update Submit

December 6, 2011

Conditions

Keywords

APLAAPSStrokeminor anti bodymajor anti bodyAPLA antibodies in Serum

Study Arms (2)

treatment

Stroke patients

Controls

healthy controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir health center

Kfar Saba, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Ischemic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Yair Levy, Prof.

CONTACT

Narin N Carmel, B.Sc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 7, 2011

Study Start

December 1, 2011

Primary Completion

March 1, 2012

Study Completion

September 1, 2012

Last Updated

December 7, 2011

Record last verified: 2011-12

Locations