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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02963545
Other study ID # P11/25_AVC-TSK
Secondary ID
Status Completed
Phase N/A
First received September 16, 2016
Last updated November 16, 2016
Start date October 2012
Est. completion date May 2016

Study information

Verified date November 2016
Source Versailles Hospital
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date May 2016
Est. primary completion date November 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Usual care patients in neurology department
patients characteristics, history, clinical signs chronology and usual medical care by the emergency units, cerebral infarction area
Biological:
blood and urines sampling
Collection samples for biochemical determinations of serotonin pathway and kynurenine pathway parameters determinations
Procedure:
Psychiatric evaluation
depression scale, impulsivity scale, hostility scale , tobacco consumption questioning

Locations

Country Name City State
France Centre Hospitalier de Versailles Le Chesnay

Sponsors (1)

Lead Sponsor Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Patient characteristics, history, clinical signs chronology For patients: patient characteristics, history, clinical signs chronology and medical care by pre-hospital then hospital neurology intensive care, MRI diagnosis validation, cerebral infarction area.
For controls : patient characteristics, history.
Day 1 Yes
Other Patient characteristics, clinical signs patients characteristics, clinical signs and medical care by hospital neurology intensive care. Day 2 Yes
Other Patient characteristics, clinical signs Patients characteristics, clinical signs and medical care. Month 3 Yes
Other Depression scale Interview with the patient, or a patient closely related, or a physician. Scale for depression scores (simplified depression scale from Whooley 2006), concerning the 2 weeks before stroke Day 2 Yes
Other Impulsivity scale Interview with the patient, or a patient closely related, or a physician. Scale for impulsivity scores ( Barratt Impulsiveness scale), concerning the 2 weeks before stroke Day 2 Yes
Primary Measure of serotonin pathway parameters concentrations in blood and urine samples platelet serotonin (nM), plasma serotonin (nM), urine serotonin (nM) , plasma 5-HIAA (nM) , urine 5-HIAA (nM) concentrations using three different HPLC systems and methods. Day 1 Yes
Primary Measure of serotonin pathway parameters in blood samples Blood platelets assessements of serotonin (5-HT) transporters using [3H]paroxetine ligand ( fmol/mg proteins) and 5-HT2A receptors using [3H]MDL-100,907 ligand ( fmol/mg proteins) Day 1 Yes
Primary Measure of serotonin pathway parameters in blood and urine samples platelet serotonin (nM), plasma serotonin (nM), urine serotonin (nM) , plasma 5-HIAA (nM) , urine 5-HIAA (nM) concentrations using three different HPLC systems and methods Day 2 Yes
Primary Measure of serotonin pathway parameters in blood and urine samples platelet serotonin (nM), plasma serotonin (nM), urine serotonin (nM) , plasma 5-HIAA (nM) , urine 5-HIAA (nM) concentrations using three different HPLC systems and methods Month 3 Yes
Primary Measure of kynurenin pathway parameters in blood samples The first and regulatory enzyme of the kynurenine pathway is the indoleamine-2,3-dioxygenase (IDO). Plasma tryptophan (µM) and plasma kynurenine (µM) concentrations [Trp] and [Kyn] were quantified with HPLC method. [Trp] / [Kyn] ratio (in AU, Arbitrary Units) was used as index for IDO activity . Day 1 Yes
Primary Measure of kynurenin pathway parameters in blood samples The first and regulatory enzyme of the kynurenine pathway is the indoleamine-2,3-dioxygenase (IDO). Plasma tryptophan (µM) and plasma kynurenine (µM) concentrations [Trp] and [Kyn] were quantified with HPLC method. [Trp] / [Kyn] ratio (in AU, Arbitrary Units) was used as index for IDO activity . Day 2 Yes
Primary Measure of kynurenin pathway parameters in blood samples The first and regulatory enzyme of the kynurenine pathway is the indoleamine-2,3-dioxygenase (IDO). Plasma tryptophan (µM) and plasma kynurenine (µM) concentrations [Trp] and [Kyn] were quantified with HPLC method. [Trp] / [Kyn] ratio (in AU, Arbitrary Units) was used as index for IDO activity . Month 3 Yes
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