NCT02974192

Brief Summary

Ischemic stroke accounts for the majority of stroke cases and constitutes a major cause of death and disability in industrial world. Inflammation has been reported to constitute a major component of ischemic stroke pathology. The brain responds to ischemic injury with an acute andprolonged inflammatory process. Few studies have investigated the relationship between acute biomarkers of inflammation and functional outcome following stroke

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

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

November 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

November 23, 2016

Last Update Submit

January 14, 2017

Conditions

Stroke

Keywords

Ischemic strokeSoluble CD40 LigandNeopetrinstroke risk factorsfunctional outcome

Outcome Measures

Primary Outcomes (2)

  • Neopterin level

    will be measured by using standard laboratory methods on the first day of admission

    Within the first 24 hours

  • Soluble CD40 Ligand

    will be measured by using standard laboratory methods on the first day of admission

    Within the first 24 hours

Secondary Outcomes (3)

  • Stroke subtype

    Within the first 24 hours

  • The clinical stroke syndrome

    Within the first 24 hours

  • Stroke severity

    Within the first 24 hours

Interventions

NeopterinOTHER

Neopterin will be measured by using standard laboratory methods on the first day of admission.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with first -ever acute onset ischemic stroke within 24-48 hours

You may qualify if:

  • Onset is within one week
  • Confirmed stroke by brain CAT and / or MRI scan infarction

You may not qualify if:

  • Cognitive and mental changes
  • Recurrent stroke
  • Hepatic and renal impairment
  • Endocrinal diseases
  • Steroid therapy
  • Previous fractures
  • brain neoplasm,
  • Autoimmune diseases
  • History of acute and chronic inflammatory diseases
  • Malignancy,
  • Trauma
  • Surgery
  • Acute vascular diseases that occurred within four weeks prior the onset of stroke History myocardial infarction ˂3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, Asyut Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

StrokeIschemic Stroke

Interventions

Neopterin

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BiopterinsPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and Coenzymes

Study Officials

  • Sayed k Abd-Elshafy, MD

    Associate professor of anesthesia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sayed K Abd-Elshafy, MD

CONTACT

0020882413203sayed_k_72@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate profossor of anesthesia

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 28, 2016

Study Start

November 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

EG(1)