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Completed

NCT Number: NCT02963545

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

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.

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Key information

Conditions

Cerebral Infarction Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Infarction Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de Versailles

Le Chesnay, 78150, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual care patients in neurology department

Other

patients characteristics, history, clinical signs chronology and usual medical care by the emergency units, cerebral infarction area

blood and urines sampling

Biological

Collection samples for biochemical determinations of serotonin pathway and kynurenine pathway parameters determinations

Psychiatric evaluation

Procedure

depression scale, impulsivity scale, hostility scale , tobacco consumption questioning

Primary outcomes

  1. Measure of serotonin pathway parameters concentrations in blood and urine samples

    Time frame: Day 1

    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.

  2. Measure of serotonin pathway parameters in blood samples

    Time frame: Day 1

    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)

  3. Measure of serotonin pathway parameters in blood and urine samples

    Time frame: Day 2

    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

  4. Measure of serotonin pathway parameters in blood and urine samples

    Time frame: Month 3

    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

  5. Measure of kynurenin pathway parameters in blood samples

    Time frame: Day 1

    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 .

  6. Measure of kynurenin pathway parameters in blood samples

    Time frame: Day 2

    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 .

  7. Measure of kynurenin pathway parameters in blood samples

    Time frame: Month 3

    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 .

Other outcomes

  1. Patient characteristics, history, clinical signs chronology

    Time frame: Day 1

    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.

  2. Patient characteristics, clinical signs

    Time frame: Day 2

    patients characteristics, clinical signs and medical care by hospital neurology intensive care.

  3. Patient characteristics, clinical signs

    Time frame: Month 3

    Patients characteristics, clinical signs and medical care.

    .

  4. Depression scale

    Time frame: Day 2

    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

  5. Impulsivity scale

    Time frame: Day 2

    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

Sponsors and collaborators

Lead sponsor

Versailles Hospital

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Nov 15, 2016
Registry last updated
Nov 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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