Neopterin Effects on Ischemic Stroke

Neoptrin, Soluble CD40-ligand and Ischemic Stroke: a Clinical Perspective

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

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Other: Neopterin

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke subtype	will be classified according to the criteria of Trial of Org 10172 in acute Stroke Treatment (TOAST) classification	Within the first 24 hours
The clinical stroke syndrome	will be determined by applying the criteria of the Oxfordshire Community Stroke project (OCSP)	Within the first 24 hours
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.	Within the first 24 hours

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Sayed K Abd-Elshafy, MD, Associate professor of anesthesia

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: November 23, 2016
• First Submitted That Met QC Criteria: November 25, 2016
• First Posted (Estimate): November 28, 2016

Study Record Updates

• Last Update Posted (Estimate): January 18, 2017
• Last Update Submitted That Met QC Criteria: January 14, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: functional outcome; Ischemic stroke; Soluble CD40 Ligand; Neopetrin; stroke risk factors
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: IIRB0000871432

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED