Neopterin Effects on Ischemic Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02974192
• Other study ID #: IIRB0000871432
• Status: Recruiting
• Phase: N/A
• First received: November 23, 2016
• Last updated: January 14, 2017
• Start date: November 2016
• Est. completion date: March 2017

Study information

• Verified date: January 2017
• Source: Assiut University
• Contact: Sayed K Abd-Elshafy, MD
• Phone: 0020882413203
• Email: sayed_k_72[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neopterin level	will be measured by using standard laboratory methods on the first day of admission	Within the first 24 hours
Primary	Soluble CD40 Ligand	will be measured by using standard laboratory methods on the first day of admission	Within the first 24 hours
Secondary	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
Secondary	The clinical stroke syndrome	will be determined by applying the criteria of the Oxfordshire Community Stroke project (OCSP)	Within the first 24 hours
Secondary	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