Clinical trial NCT02974192: Neopterin Effects on Ischemic Stroke
Official title: Neoptrin, Soluble CD40-ligand and Ischemic Stroke: a Clinical Perspective
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: Ischemic stroke
Soluble CD40 Ligand
Neopetrin
stroke risk factors
functional outcome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-11-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with first -ever acute onset ischemic stroke within 24-48 hours

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Neopterin level
timeFrame: Within the first 24 hours
measure: Soluble CD40 Ligand
timeFrame: Within the first 24 hours
Secondary outcomes:
measure: Stroke subtype
timeFrame: Within the first 24 hours
measure: The clinical stroke syndrome
timeFrame: Within the first 24 hours
measure: Stroke severity
timeFrame: Within the first 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Associate professor of anesthesia
name: Sayed k Abd-Elshafy, MD
role: PRINCIPAL_INVESTIGATOR
References: