CClinicalTrials.gg
Status unknownNCT02974192Updated Jan 18, 2017

Neopterin Effects on Ischemic Stroke

An observational study in Stroke, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-01-18.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 80 Years
Sex
All
01

Study 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

Read the detailed description

This case -control observational prospective study will be conducted on 100 patients with first -ever acute onset ischemic stroke within 24-48 hours. Their ages ranged-years old (mean age ±years). All participants will be subjected to thorough history taking, full clinical and neurological examination. Complete neurological examination where the following clinical and demographical data will be taken; age sex, stroke etiology, presence of stroke risk factors (as smoking history , hyperlipidemia, diabetes mellitus , history of hypertension, history of transient ischemic attacks, history of myocardial infarction or any cardiac problems). Stroke subtype will be classified according to the criteria of Trial of Org 10172 in acute Stroke Treatment (TOAST) classification. The clinical stroke syndrome will be determined by applying the criteria of the Oxfordshire Community Stroke project (OCSP). Stroke severity will be assessed by Scandinavian Stroke Scale (SSS) and Modified Rankin Scale (mRS) will be measured at the time of admission. Brain imaging (either CT scan and /or MRI) will be performed after admission. Electrocardiography (ECG), Echocardiography (ECHO), Carotid and vertibrobasilar Duplex will be done for all patients. Blood samples will be drawn for assessment of complete blood picture (CBC), Random blood glucose levels, renal function tests (RFT), liver function tests (LFT), thyroid function tests (TFT), Lipid profile, Soluble CD40 Ligand and Neopetrin by using standard laboratory methods on the first day of admission.

02

Conditions studied

  • Stroke

Keywords

  • Ischemic stroke
  • Soluble CD40 Ligand
  • Neopetrin
  • stroke risk factors
  • functional outcome
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 100 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

  • 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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • OtherNeopterin

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

06

What researchers measure

Primary outcomes

  1. Neopterin level

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

    Time frame: Within the first 24 hours

  2. Soluble CD40 Ligand

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

    Time frame: Within the first 24 hours

Secondary outcomes

  1. Stroke subtype

    will be classified according to the criteria of Trial of Org 10172 in acute Stroke Treatment (TOAST) classification

    Time frame: Within the first 24 hours

  2. The clinical stroke syndrome

    will be determined by applying the criteria of the Oxfordshire Community Stroke project (OCSP)

    Time frame: Within the first 24 hours

  3. Stroke severity

    Stroke severity will be assessed by Scandinavian Stroke Scale (SSS) and Modified Rankin Scale (mRS) will be measured at the time of admission.

    Time frame: Within the first 24 hours

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02974192
Lead sponsor
Assiut University
Responsible party
Sayed Kaoud Abd-Elshafy (Associate profossor of anesthesia, Assiut University) — Principal investigator
First posted
Nov 28, 2016
Start date
Nov 2016
Primary completion
Mar 2017 (estimated)
Completion
Mar 2017 (estimated)
Last update
Jan 18, 2017

Study contacts

Sayed K Abd-Elshafy, MD
Contact
sayed_k_72@yahoo.com
0020882413203
Sayed k Abd-Elshafy, MD
principal investigator · Associate professor of anesthesia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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