TSK (Tryptophan - Serotonin - Kynurenine) Biomarkers Assessment in Stroke
NCT ID: NCT02963545
Last Updated: 2016-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2012-10-31
2016-05-31
Brief Summary
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Depression is the second risk factor for stroke as tobacco smoking following hypertension. Peripheral abnormalities in serotonin parameters were described in depression and tobacco smoking. The investigators hypothesized dysregulations in pathways of serotonin (5-HT), which has notably complex vasomotor effects and of kynurenine which could have cognitive dysfunction effects.
The aim of this study is to evaluate simultaneously the involvement of serotonin and kynurenine pathways parameters in patients suffering from a cerebral infarction shortly after the onset (less than 4 hours and a half), within a 2 days follow-up (Day 1 and Day 2) and 3 months after the cerebral infarction.
Detailed Description
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The primary objective was the measurements of serotonin and kynurenine pathways parameters which were performed in blood and urine samples using different HPLC techniques and of serotonin transporters and receptors which were determined in blood platelets. The results in patients were compared to those measured in controls matched for age, gender, tobacco consumption and season of inclusion.
The secondary objective was to evaluate the potential relationships between these 5-HT and Kyn pathways biomarkers concentrations, MAOA and IDO enzymatic activations and clinical outcome and criteria.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Patients presenting cerebral infarction
no intervention of health product administration,
Usual care patients in neurology department
patients characteristics, history, clinical signs chronology and usual medical care by the emergency units, cerebral infarction area
blood and urines sampling
Collection samples for biochemical determinations of serotonin pathway and kynurenine pathway parameters determinations
Psychiatric evaluation
depression scale, impulsivity scale, hostility scale , tobacco consumption questioning
Historical controls
no intervention of health product administration, patients characteristics, history, matched with patients for age, gender, tobacco consumption and season of inclusion, free of neurologic or psychiatric disease or psychotropic medications or medications known to impact on serotonin
blood and urines sampling
Collection samples for biochemical determinations of serotonin pathway and kynurenine pathway parameters determinations
Interventions
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Usual care patients in neurology department
patients characteristics, history, clinical signs chronology and usual medical care by the emergency units, cerebral infarction area
blood and urines sampling
Collection samples for biochemical determinations of serotonin pathway and kynurenine pathway parameters determinations
Psychiatric evaluation
depression scale, impulsivity scale, hostility scale , tobacco consumption questioning
Eligibility Criteria
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Inclusion Criteria
* Cerebral infarction with a medical care to emergencies less than 4.30 hours after the symptoms onset.
* Written informed consent signed by the patient, or by a trusted person then by the patient himself if permitted by his condition.
Exclusion Criteria
* Patient with subarachnoid haemorrhage, cerebral hematoma.
* Pregnant woman
* Patient under guardianship or trusteeship, or safeguard justice.
Control group :
* Matching criteria for age, gender, tobacco smoking, inclusion season
18 Years
ALL
Yes
Sponsors
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Versailles Hospital
OTHER
Responsible Party
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Odile VAROQUAUX
Investigator coordinator
Principal Investigators
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Odile SPREUX-VAROQUAUX, PhD
Role: PRINCIPAL_INVESTIGATOR
Pharmacology, Versailles Hospital and Versailles University
Fernando PICO, Neurology Department head
Role: STUDY_DIRECTOR
Versailles Hospital
Locations
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Centre Hospitalier de Versailles
Le Chesnay, , France
Countries
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Other Identifiers
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P11/25_AVC-TSK
Identifier Type: -
Identifier Source: org_study_id