NCT02963545

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

2.1 years

First QC Date

September 16, 2016

Last Update Submit

November 16, 2016

Conditions

Cerebral Infarction

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Other Outcomes (5)

  • Patient characteristics, history, clinical signs chronology

    Day 1

  • Patient characteristics, clinical signs

    Day 2

  • Patient characteristics, clinical signs

    Month 3

  • +2 more other outcomes

Study Arms (2)

Patients presenting cerebral infarction

EXPERIMENTAL

no intervention of health product administration,

Other: Usual care patients in neurology departmentBiological: blood and urines samplingProcedure: Psychiatric evaluation

Historical controls

OTHER

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

Biological: blood and urines sampling

Interventions

Usual care patients in neurology departmentOTHER

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

Patients presenting cerebral infarction
blood and urines samplingBIOLOGICAL

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

Historical controlsPatients presenting cerebral infarction
Psychiatric evaluationPROCEDURE

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

Patients presenting cerebral infarction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 :

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Versailles

Le Chesnay, 78150, France

Location

MeSH Terms

Conditions

Cerebral Infarction

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Odile SPREUX-VAROQUAUX, PhD

    Pharmacology, Versailles Hospital and Versailles University

    PRINCIPAL INVESTIGATOR

  • Fernando PICO, Neurology Department head

    Versailles Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator coordinator

Study Record Dates

First Submitted

September 16, 2016

First Posted

November 15, 2016

Study Start

October 1, 2012

Primary Completion

November 1, 2014

Study Completion

May 1, 2016

Last Updated

November 17, 2016

Record last verified: 2016-11

Locations

FR(1)