euroactive Steroids in Acute Ischemic Stroke: association with Cognitive, Functional and Neurological Outcomes

Not Applicable

Completed

• Conditions: Acute ischemic Stroke, neurologic status, Acute Ischemic Stroke; Elderly patients; cognitive assessment, functional status.; Neuroactive steroids; Cognitive impairment; Functional impairment.

• Registration Number: TCTR20160510004
• Lead Sponsor: Hospital Militar Central Cir My ¨Dr. Cosme Argerich¨.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2014-08-13
• Study Start: 2016-05-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Age between 60 and 90 years.
Agreeing to participate in the study.
Acute Ischemic Stroke of anterior vascular territory and/or posterior vascular territory whithin 24 hours of onset.
Nine or more points in the Glasgow Coma Scale.
Female patients in menopause.
Patients without cognitive impairment before AIS according to family reference
Acceptance of the next of kin proxy in case the participant has sensory impairment

Exclusion Criteria

Age <60 or > 90 years.
Hemorrhagic Stroke.
Transient ischemic attack (TIA).
Acute Ischemic Stroke after 24 hours of onset.
Hormonal replacement therapy.
Immunossupresive therapy in the last month before AIS (Example corticosteroids).
Acute infection (Example, pneumonia, urinary tract infection).
Diagnosis of oncologic disease in the last month before AIS.
Diagnosis of endocrinologic disease in the last month before AIS.
Acute or long-term psychiatric illness.
No agreement to participate in the study
Eight or less points in the Glasgow Coma Scale.
Female patients with menstrual cycle or in the perimenopause.
Patients with kidney or hepatic illness.
Patients with cognitive impairment before AIS.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
euroactive steroids in plasma In the early morning (07 to 09 AM) Electrochemiluminescence immunoassay (ECLIA) and immunoassay chemiluminescent microparticle (CMIA) ,Neurologic status In the early morning (07 to 09 AM) National Institute of health stroke scale at the time of hospitalization ,Cognitive assessment In the early morning (07 to 09 AM) (1) Test photos (13) and (2) the abbreviated questionnaire of Pfeiffer,Functional status In the early morning (07 to 09 AM) modified Rankin Scale

Secondary Outcome Measures

Name	Time	Method
stroke subtypes In the early morning (07 to 09 AM) Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria,hypertension In the early morning (07 to 09 AM) self-reported history of hypertension or using antihypertensive drugs,diabetes mellitus (DM) In the early morning (07 to 09 AM) history of DM or using hypoglycemic medications at discharge,dyslipidemias In the early morning (07 to 09 AM) self-reported history of all types of dyslipidemia or oral antidyslipidemia drugs or using antidysli,atrial fibrillation In the early morning (07 to 09 AM) history of AF, confirmed by at least one electrocardiogram or the presence of arrhythmia during hosp,modifiable lifestyle factors In the early morning (07 to 09 AM) smoking, alcohol consumption, and obesity (body mass index >30 kg/m2).