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
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
- 是
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
Odile VAROQUAUX
Investigator coordinator
Versailles Hospital
