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Neuroactive Steroids in Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT02914106
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):
Sebastian Casas, Hospital Militar Central, Argentina

Brief Summary:

Despite several scientific and technological advances, there is no single neuroprotective treatment that can reverse the brain damage after acute ischemic stroke (AIS). Neuroactive steroids are cholesterol-derived hormones that have the ability to modulate the normal and pathologic nervous system employing genomic and non genomic mechanisms.

In this work, we first investigated if AIS affects the plasma concentration of five neuroactive steroids (cortisol, estradiol, progesterone, testosterone and 3-alpha androstenediol glucuronide). Second, we studied if levels of circulating steroids associate with neurological, cognitive and functional outcome in a cohort of 60 to 90 year-old male and female patients with AIS.

For this purpose, we recruited patients who were hospitalized at the Emergency Room of the Central Military Hospital within the first 24 hours after stroke onset. We designed two experimental groups, each one composed of 30 control subjects and 30 AIS patients, both males and females. The assessment of neurological deficit was performed with the NIHSS and the tests used for the functional and cognitive status were: (1) modified Rankin Scale; (2) Photo test and (3) abbreviated Pfeiffer's mental status questionnaire.


Condition or disease Intervention/treatment
Ischemic Stroke Other: Observational Study

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Neuroactive Steroids in Acute Ischemic Stroke: Association With Cognitive, Functional and Neurological Outcomes.
Study Start Date : June 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Group/Cohort Intervention/treatment
Control group
Sixty-90 year-old subjects were randomly selected and distributed in two experimental groups: 1) a control group, involving subjects without physical or psychiatric illness, and 2) an Acute Ischemic Stroke group (AIS group).
Other: Observational Study
Patients were diagnosed for AIS by a certified neurologist at the Emergency Room of the Central Military Hospital. Neurological, cognitive and functional status were determined by NIHSS score, Photo test, Pfeiffer mental status score and by modified Rankin score respectively. A sample of venous blood was withdrawn in the early morning (07 to 09 AM) after assessment of neurological and cognitive status.

Acute Ischemic Stroke group
Patients with diagnosis of AIS within the 24 hours of their neurovascular event.
Other: Observational Study
Patients were diagnosed for AIS by a certified neurologist at the Emergency Room of the Central Military Hospital. Neurological, cognitive and functional status were determined by NIHSS score, Photo test, Pfeiffer mental status score and by modified Rankin score respectively. A sample of venous blood was withdrawn in the early morning (07 to 09 AM) after assessment of neurological and cognitive status.




Primary Outcome Measures :
  1. Neurological impairment by the Institute of health stroke scale [ Time Frame: Into 24 hours of Acute Ischemic Stroke ]
    The assessment of neurologic status during the AIS was carried out with 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)


Secondary Outcome Measures :
  1. Cognitive impairment by photos Test. [ Time Frame: Into 24 hours of Acute Ischemic Stroke ]
    Test photos evaluated memory, object recognition and verbal fluency. This test is not influenced by the level of education of the patient, it is simple and brief in duration (4 minutes).

  2. Cognitive impairment by Pfeiffer Test [ Time Frame: Into 24 hours of Acute Ischemic Stroke ]
    The Pfeiffer Test studied orientation, calculation, recent and remote memory, and information about daily events.

  3. Functional dependence for daily activities by Rankin Scale [ Time Frame: Into 24 hours of Acute Ischemic Stroke ]
    The functional status of patients with AIS was measured with the modified Rankin Scale at the time of discharge. Data was collected through an interview designed for the purpose of reducing the variability between evaluators.

  4. Quantitation of neuroactive steroids in plasma by electrochemiluminescence immunoassay (ECLIA). [ Time Frame: Into 24 hours of Acute Ischemic Stroke ]
    The measurement of estradiol (Estradiol EII) and progesterone (Progesterone II) was performed by electrochemiluminescence immunoassay (ECLIA).

  5. Quantitation of neuroactive steroids in plasma by an immunoassay chemiluminescent microparticle (CMIA). [ Time Frame: Into 24 hours of Acute Ischemic Stroke ]
    The measurement of cortisol and testosterone, they were determined by an immunoassay chemiluminescent microparticle (CMIA) procedure, using a Team Architect i1000, Abbott Laboratories, Middletown, USA.

  6. Quantitation of neuroactive steroids in plasma by radioimmunoassay (RIA). [ Time Frame: Into 24 hours of Acute Ischemic Stroke ]
    The measurement of alpha-3-androstenediolglucoronide was determined by radioimmunoassay (RIA) using a DS.



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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Sixty-90 year-old subjects were randomly selected and distributed in two experimental groups: 1) a control group, involving subjects without physical or psychiatric illness, and 2) an AIS group, consisting of: patients with diagnosis of AIS within the 24 hours of their neurovascular event. Subjects were distributed between groups so that each group contained 30 patients (15 women and 15 men).
Criteria

Inclusion Criteria:

  • Age between 60 and 90 years.
  • Agreeing to participate in the study.
  • Fourteen or more points in the Glasgow Coma Scale.
  • Female control in menopause.
  • Control subjects without cognitive impairment according to certified neurologist.

Exclusion Criteria:

  • Age <60 or > 90 years.
  • Hormonal replacement therapy.
  • Immunossupresive therapy in the last month (Example corticosteroids).
  • Acute infection (Example, pneumonia, urinary tract infection).
  • Diagnosis of oncologic disease in the last month.
  • Diagnosis of endocrinologic disease in the last month.
  • Acute or long-term psychiatric illness.
  • No agreement to participate in the study
  • Thirteen 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914106


Sponsors and Collaborators
Hospital Militar Central, Argentina
Investigators
Principal Investigator: Sebastian Casas, PhD Central Military Hospital

Publications of Results:
Other Publications:
Responsible Party: Sebastian Casas, PhD, Hospital Militar Central, Argentina
ClinicalTrials.gov Identifier: NCT02914106     History of Changes
Other Study ID Numbers: (C.I.R.E.C.) Act N ° 308
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Sebastian Casas, Hospital Militar Central, Argentina:
Neuroactive steroids
Acute Ischemic Stroke
Patients

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia