Neopterin Effects on Ischemic Stroke

• Conditions: Stroke

• Registration Number: NCT02974192
• Lead Sponsor: Assiut University

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

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-11-25
• Study First Posted: 2016-11-28
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-14
• Last Update Posted: 2017-01-18
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neopterin level	Within the first 24 hours	will be measured by using standard laboratory methods on the first day of admission
Soluble CD40 Ligand	Within the first 24 hours	will be measured by using standard laboratory methods on the first day of admission

Secondary Outcome Measures

Name	Time	Method
The clinical stroke syndrome	Within the first 24 hours	will be determined by applying the criteria of the Oxfordshire Community Stroke project (OCSP)
Stroke subtype	Within the first 24 hours	will be classified according to the criteria of Trial of Org 10172 in acute Stroke Treatment (TOAST) classification
Stroke severity	Within the first 24 hours	Stroke severity will be assessed by Scandinavian Stroke Scale (SSS) and Modified Rankin Scale (mRS) will be measured at the time of admission.

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt