TSK (Tryptophan - Serotonin - Kynurenine) Biomarkers Assessment in Stroke

Versailles Hospital

Status: Completed

Conditions: Cerebral Infarction

Treatments: Other: Usual care patients in neurology department; Biological: blood and urines sampling; Procedure: Psychiatric evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT02963545

P11/25_AVC-TSK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Patients presenting cerebral infarction

Experimental group

Description:

no intervention of health product administration,

Treatment:

Biological: blood and urines sampling

Other: Usual care patients in neurology department

Procedure: Psychiatric evaluation

Historical controls

Other group

Description:

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

Treatment:

Biological: blood and urines sampling