Clinical trial NCT02963545: TSK (Tryptophan - Serotonin - Kynurenine) Biomarkers Assessment in Stroke
Official title: Simultaneous Assessments of Serotonin and Kynurenine Pathways Parameters in Patients Shortly (Less Than 4 Hours and a Half) After the Onset of a Cerebral Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Infarction
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2016-11-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Single-center, prospective, descriptive and biomedical research with controls, without health product.

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: Tryptophan (TRP), an essential aminoacid, is metabolized in the serotonin (5-HT) or in the kynurenine (KYN) pathway. Serotonin is catabolized to 5-HIAA (5-hydroxyindole amino acid) by monoamine oxidase A (MAOA). The TRP to KYN transformation is regulated by indoleamine 2,3-dioxygenase (IDO).

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.

Eligibility criteria: Study population : patients who had positive MRI diagnosis of cerebral infarction less than 4.30 hours after the clinical onset.

Experimental group :

Inclusion Criteria:

* Age ≥ 18 ans
* 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:

* Cerebral infarction with a medical care to emergencies more than 4.30 hours after the symptoms onset.
* 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

Primary outcomes:
measure: Measure of serotonin pathway parameters concentrations in blood and urine samples
timeFrame: Day 1
measure: Measure of serotonin pathway parameters in blood samples
timeFrame: Day 1
measure: Measure of serotonin pathway parameters in blood and urine samples
timeFrame: Day 2
measure: Measure of serotonin pathway parameters in blood and urine samples
timeFrame: Month 3
measure: Measure of kynurenin pathway parameters in blood samples
timeFrame: Day 1
measure: Measure of kynurenin pathway parameters in blood samples
timeFrame: Day 2
measure: Measure of kynurenin pathway parameters in blood samples
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
measure: Patient characteristics, history, clinical signs chronology
timeFrame: Day 1
measure: Patient characteristics, clinical signs
timeFrame: Day 2
measure: Patient characteristics, clinical signs
timeFrame: Month 3
measure: Depression scale
timeFrame: Day 2
measure: Impulsivity scale
timeFrame: Day 2
Locations:
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles
Study officials:
affiliation: Pharmacology, Versailles Hospital and Versailles University
name: Odile SPREUX-VAROQUAUX, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Versailles Hospital
name: Fernando PICO, Neurology Department head
role: STUDY_DIRECTOR
References: