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临床试验/NCT02963545
NCT02963545已完成不适用

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

Versailles Hospital2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2012年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28
试验地点
2
主要终点
Measure of serotonin pathway parameters concentrations in blood and urine samples

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Measure of serotonin pathway parameters concentrations in blood and urine samples

时间窗: 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.

Measure of serotonin pathway parameters in blood and urine samples

时间窗: 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

Measure of serotonin pathway parameters in blood samples

时间窗: 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)

Measure of kynurenin pathway parameters in blood samples

时间窗: 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 .

次要结局

未报告次要终点

研究者

发起方
Versailles Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Odile VAROQUAUX

Investigator coordinator

Versailles Hospital

研究点 (2)

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