Ischemic Stroke Clinical Trial
— CortisolOfficial title:
Changes in Plasma Cortisol, Brain-derived Neurotrophic Factor, and Nitrites in Patients With Acute Ischemic Stroke
Verified date | August 2017 |
Source | Hospital Militar Central, Argentina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Acute ischemic stroke (AIS) represents an economical challenge for health systems all over the globe. Despite increasing knowledge of the pathophysiology of AIS, there is no satisfactory treatment to revert the resulting brain damage. Changes of neuroactive steroids have been found in different neurological diseases. In this regard, the investigators have previously demonstrated that old patients with AIS show changes of plasma cortisol and estradiol concentrations, in that increased steroid levels are associated with a deterioration of neurological status and a worse cognitive decline. The present study assessed in patients with AIS if changes of behavior, brain-derived neurotrophic factor (BDNF) and nitrites (NO-2) (nitric oxide soluble metabolite) bear a relationship with the degree of hypercortisolism. To this purpose, the investigators recruited patients hospitalized at the Central Military Hospital emergency room within the first 24 hours of AIS. Subjects were divided into two groups, each one composed of 40 control subjects and 40 AIS patients, including men and women. The neurological condition was assessed using the NIHSS and the cognitive status with the Montreal Cognitive Assessment (MoCA test). The emotional status was evaluated using the Montgomery-Asberg Depression Rating Scale (MADRS), whereas the Modified Rankin Scale (MRS) was used to determine the functional condition. BDNF and NO-2 plasma levels were measured by ELISA and the Griess reaction method, respectively.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 1, 2016 |
Est. primary completion date | December 1, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 90 Years |
Eligibility |
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. - Immunosuppressive 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Hospital Militar Central, Argentina |
Casas S, García S, Cabrera R, Nanfaro F, Escudero C, Yunes R. Progesterone prevents depression-like behavior in a model of Parkinson's disease induced by 6-hydroxydopamine in male rats. Pharmacol Biochem Behav. 2011 Oct;99(4):614-8. doi: 10.1016/j.pbb.201 — View Citation
Casas S, Giuliani F, Cremaschi F, Yunes R, Cabrera R. Neuromodulatory effect of progesterone on the dopaminergic, glutamatergic, and GABAergic activities in a male rat model of Parkinson's disease. Neurol Res. 2013 Sep;35(7):719-25. doi: 10.1179/174313281 — View Citation
Casas S, Gonzalez Deniselle MC, Gargiulo-Monachelli GM, Perez AF, Tourreilles M, Mattiazzi M, Ojeda C, Lotero Polesel D, De Nicola AF. Neuroactive Steroids in Acute Ischemic Stroke: Association with Cognitive, Functional, and Neurological Outcomes. Horm M — View Citation
Escudero C, Casas S, Giuliani F, Bazzocchini V, García S, Yunes R, Cabrera R. Allopregnanolone prevents memory impairment: effect on mRNA expression and enzymatic activity of hippocampal 3-a hydroxysteroid oxide-reductase. Brain Res Bull. 2012 Feb 10;87(2 — View Citation
Ghersi MS, Casas SM, Escudero C, Carlini VP, Buteler F, Cabrera RJ, Schiöth HB, de Barioglio SR. Ghrelin inhibited serotonin release from hippocampal slices. Peptides. 2011 Nov;32(11):2367-71. doi: 10.1016/j.peptides.2011.07.015. Epub 2011 Jul 27. — View Citation
Yunes R, Casas S, Gaglio E, Cabrera R. Progesterone Exerts a Neuromodulatory Effect on Turning Behavior of Hemiparkinsonian Male Rats: Expression of 3 a -Hydroxysteroid Oxidoreductase and Allopregnanolone as Suggestive of GABAA Receptors Involvement. Park — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neurological déficit | The neurological state during AIS was quantified by the National Institute of Health stroke scale at the time of hospitalization (NIHSS,available at http://www.ninds.nih.gov/doctors/NIH_Stroke_Scale.pdf | Into 24 hours of Acute Ischemic Stroke | |
Secondary | Cognition | The cognitive test used was the Montreal Cognitive Assessment (MoCA test). | Into 24 hours of Acute Ischemic Stroke | |
Secondary | Emotional state | Patients with AIS were evaluated on the Montgomery-Asberg depression scale (MADRS) | Into 24 hours of Acute Ischemic Stroke | |
Secondary | Functional dependency of daily life activities | The functional state of the AIS patients was assessed by the modified Rankin scale at the time of entering the admission floor. | Into 24 hours of Acute Ischemic Stroke | |
Secondary | Cortisol | Plasma cortisol concentration was determined by chemiluminescent microparticle immunoassay (CMIA), using Team Architect i1000, Abbott Laboratories, Middletown, USA. | Into 24 hours of Acute Ischemic Stroke | |
Secondary | Quantification of nitrites concentration (NO-2) | Levels of NO-2, nitric oxide soluble metabolite (ON.) in water, were measured spectrophotometrically at 543 nm absorbance by the Griess reactio | Into 24 hours of Acute Ischemic Stroke | |
Secondary | BDNF quantification in plasma | Plasma BDNF concentration was measured by enzyme-linked immunosorbent assay (ELISA) | Into 24 hours of Acute Ischemic Stroke |
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