Cerebral InfarctionNCT02963545
TSK (Tryptophan - Serotonin - Kynurenine) Biomarkers Assessment in Stroke
A study testing blood and urines sampling and Psychiatric evaluation in people with Cerebral Infarction, run by Versailles Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- blood and urines sampling and Psychiatric evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed 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.
- Conditions
- Cerebral Infarction
- Being tested
- Usual care patients in neurology department, blood and urines sampling, Psychiatric evaluation
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual care patients in neurology departmentOther
patients characteristics, history, clinical signs chronology and usual medical care by the emergency units, cerebral infarction area
blood and urines samplingBiological
Collection samples for biochemical determinations of serotonin pathway and kynurenine pathway parameters determinations
Psychiatric evaluationProcedure or surgery
depression scale, impulsivity scale, hostility scale , tobacco consumption questioning
| Study group | Role | What they receive |
|---|---|---|
| Patients presenting cerebral infarction | Experimental | no intervention of health product administration, Receives: Other: Usual care patients in neurology department; Biological: blood and urines sampling; Procedure: 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 Receives: Biological: blood and urines sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startOct 2012
- Primary completionNov 2014
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Odile VAROQUAUX, Versailles Hospital
- Investigators
- Odile SPREUX-VAROQUAUX, PhD, Principal investigator, Pharmacology, Versailles Hospital and Versailles UniversityFernando PICO, Neurology Department head, Study director, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963545
- Sponsor's protocol ID
- P11/25_AVC-TSK
- Status last verified
- Nov 2016
- First submitted
- 16 Sep 2016
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02963545
- Acronym / sponsor ID
- P11/25_AVC-TSK
- Conditions
- Cerebral Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients presenting cerebral infarction | Experimental | Other: Usual care patients in neurology department, Biological: blood and urines sampling, Procedure: Psychiatric evaluationno intervention of health product administration, |
| Historical controls | Other | Biological: blood and urines samplingno 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
- Matching criteria for age, gender, tobacco smoking, inclusion season
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual care patients in neurology departmentpatients characteristics, history, clinical signs chronology and usual medical care by the emergency units, cerebral infarction area | Other | Patients presenting cerebral infarction |
| blood and urines samplingCollection samples for biochemical determinations of serotonin pathway and kynurenine pathway parameters determinations | Biological | Historical controls, Patients presenting cerebral infarction |
| Psychiatric evaluationdepression scale, impulsivity scale, hostility scale , tobacco consumption questioning | Procedure or surgery | Patients presenting cerebral infarction |
Primary outcome
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.
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)
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
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
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 .
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 .
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 .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Odile SPREUX-VAROQUAUX, PhD principal investigator
Pharmacology, Versailles Hospital and Versailles University
Fernando PICO, Neurology Department head study director
Versailles Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood and urines sampling and Psychiatric evaluation in people with Cerebral Infarction, run by Versailles Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of serotonin pathway parameters concentrations in blood and urine samples (time frame: Day 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2016.