Stroke, IschemicIBIS-CTNCT04253275
Identification of Biomarkers in Ischemic Stroke - Clinical Trial
A study testing blood samples and MRI without injection in people with Stroke, Ischemic and Stroke Hemorrhagic, run by University Hospital, Brest at 1 site in France.
Trial summary
The objective of the study is to determine RNA blood biomarker based on 9 genes already identified in experimental studies, whose expression would be significantly increased in patient with ischemic stroke compared to controls. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Ischemic, Stroke Hemorrhagic
- What is being tested?
- blood samples and MRI without injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2020to 6 Feb 2024
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For ischemic stroke :
- Age > 18-year-old
- Ischemic stroke diagnosed on clinical presentation and cerebral imaging (CT or MRI imaging)
- Initial NIHSS score > 0 at the time of clinical examination
- Patients with multimodal imaging either through MRI or CT perfusion and supra-aortic vessels and intra-cerebral vessels (Willis circle) imaging <0
- Procedure of signed consent in situation of emergency : consent of the patient if he has the possibility to sign or his representative if he is present
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- For hemorragic stroke :
- Age > 18 year-old
- Hemorrhagic stroke diagnosed on clinical presentation and cerebral imaging (CT or MRI imaging)
- Initial NIHSS score > 0 at the time of clinical examination
- Hemorrhagic patients are paired for age and sex with ischemic patients
- Procedure of signed consent in situation of emergency : consent of the patient if he has the possibility to sign or his representative if he is present
- For healthy controls :
- Age > 18 year-old
- Stroke-free standardized questionnaire
- Initial NIHSS score = 0
- Rankin score = 0
- High risk cardiovascular subjects
- Controls are paired for age, sex and cardiovascular risk measured by a score (European Heart Score) with ischemic patients
Who cannot join
- Not affiliated to social security
- Patient under legal protection or deprived of liberty by a judicial or administrative decision
- Patient whose follow-up will be impossible
- Prior stroke
- GROUP FOR ISCHEMIC STROKE :
- Patients with TIA and a negative cerebral CT or MRI
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- GROUP FOR HEMORRAGIC STROKE :
- Cerebral hemorrhage related to subarachnoid hemorrhage
- Post-traumatic hemorrhage
- Hemorrhagic transformation in patients with ischemic stroke
- GROUP FOR HEALTHY CONTROLS :
- Contraindication MRI
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study is to determine RNA blood biomarker based on 9 genes already identified in experimental studies, whose expression would be significantly increased in patient with ischemic stroke compared to controls.
Read the detailed description
This is a monocentric study. It's a case-control study with case being first-ever ischemic stroke and controls being healthy (stroke free) subject patients paired for age, sex and cardiovascular risk or hemorrhagic stroke paired for age and sex.
Patients are followed for one year. Blood samples will be taken at inclusion, 12h, 24h, 48h, 7d, 3m and 1y. Microvesicles samples will be taken at inclusion, 7d and 3M.
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic
- Being tested
- blood samples, MRI without injection
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesGenetic
Blood samples will be taken at inclusion, 12h, 24h, 48h, 7d, 3m and 1y for patients ; at inclusion, 3m and 1y for controls.
Microvesicles samples will be taken at inclusion, 7d and 3M ; at inclusion and 3M for controls.
MRI without injectionDiagnostic test
MRI at inclusion for controls
| Study group | Role | What they receive |
|---|---|---|
| Ischemic stroke patients | Other | Patients with ischemic stroke diagnosed on clinical presentation and cerebral imaging Receives: Genetic: blood samples |
| hemorragic stroke patients | Other | Patients with hemorragic stroke diagnosed on clinical presentation and cerebral imaging Receives: Genetic: blood samples |
| healthy controls | Other | Stroke-free Receives: Genetic: blood samples; Diagnostic Test: MRI without injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression (measured in log2) of each 9 targeted genes identified less than 6 hours after inclusion
Each targeted genes will be measured by quantitative reverse transcription Polymerase Chain Reaction (rt-PCR)
Measured: 6 hours after inclusion
Secondary outcomes (4)
RNA level expression across time according growth of infarction measured at inclusion and at 3 months
Each targeted genes will be measured by quantitative rt-PCR
Measured: inclusion and 3 months
RNA level expression across time according Rankin scale at three months dichotomized in good (≤ 2) and bad prognosis (> 3).
Each targeted genes will be measured by quantitative rt-PCR
Measured: at 3 months
Targeted RNA level expression according mechanism of ischemic stroke
Each targeted RNA level expression of targeted genes will be measured by quantitative rt-PCR
Measured: at 3 months
Target RNA level expression in the saliva
For 3 participants, one of each arm, a saliva sample will be collected at inclusion.
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start24 Nov 2020
- Primary completion6 Feb 2024
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serge TIMSIT, Pr, Principal investigator, serge.timsit@chu-brest.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253275
- Sponsor's protocol ID
- IBIS-CT (29BRC19.0268)
- Acronym
- IBIS-CT
- Status last verified
- Feb 2024
- First submitted
- 7 Jan 2020
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Biomarkers in Ischemic Stroke - Clinical Trial
- ClinicalTrials.gov ID
- NCT04253275
- Acronym / sponsor ID
- IBIS-CT / IBIS-CT (29BRC19.0268)
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 5 Feb 2020 (actual)
- 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.
The objective of the study is to determine RNA blood biomarker based on 9 genes already identified in experimental studies, whose expression would be significantly increased in patient with ischemic stroke compared to controls.
Detailed description
This is a monocentric study. It's a case-control study with case being first-ever ischemic stroke and controls being healthy (stroke free) subject patients paired for age, sex and cardiovascular risk or hemorrhagic stroke paired for age and sex.
Patients are followed for one year. Blood samples will be taken at inclusion, 12h, 24h, 48h, 7d, 3m and 1y. Microvesicles samples will be taken at inclusion, 7d and 3M.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ischemic stroke patients | Other | Genetic: blood samplesPatients with ischemic stroke diagnosed on clinical presentation and cerebral imaging |
| hemorragic stroke patients | Other | Genetic: blood samplesPatients with hemorragic stroke diagnosed on clinical presentation and cerebral imaging |
| healthy controls | Other | Genetic: blood samples, Diagnostic Test: MRI without injectionStroke-free |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- For ischemic stroke :
- Age > 18-year-old
- Ischemic stroke diagnosed on clinical presentation and cerebral imaging (CT or MRI imaging)
- Initial NIHSS score > 0 at the time of clinical examination
- Patients with multimodal imaging either through MRI or CT perfusion and supra-aortic vessels and intra-cerebral vessels (Willis circle) imaging <0
Key exclusion criteria (12 listed)
- Not affiliated to social security
- Patient under legal protection or deprived of liberty by a judicial or administrative decision
- Patient whose follow-up will be impossible
- Prior stroke
- Patients with TIA and a negative cerebral CT or MRI
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 |
|---|---|---|
| blood samplesBlood samples will be taken at inclusion, 12h, 24h, 48h, 7d, 3m and 1y for patients ; at inclusion, 3m and 1y for controls. Microvesicles samples will be taken at inclusion, 7d and 3M ; at inclusion and 3M for controls. | Genetic | Ischemic stroke patients, healthy controls, hemorragic stroke patients |
| MRI without injectionMRI at inclusion for controls | Diagnostic test | healthy controls |
Primary outcome
Expression (measured in log2) of each 9 targeted genes identified less than 6 hours after inclusion
Time frame: 6 hours after inclusion
Each targeted genes will be measured by quantitative reverse transcription Polymerase Chain Reaction (rt-PCR)
4 secondary outcomes
RNA level expression across time according growth of infarction measured at inclusion and at 3 months
Time frame: inclusion and 3 months
RNA level expression across time according Rankin scale at three months dichotomized in good (≤ 2) and bad prognosis (> 3).
Time frame: at 3 months
Targeted RNA level expression according mechanism of ischemic stroke
Time frame: at 3 months
Target RNA level expression in the saliva
Time frame: at inclusion
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 4 Mar 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
Serge TIMSIT, Pr principal investigator
serge.timsit@chu-brest.fr
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 samples and MRI without injection in people with Stroke, Ischemic and Stroke Hemorrhagic, run by University Hospital, Brest 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 19 inclusion and 12 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 4 Mar 2024. 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?
Expression (measured in log2) of each 9 targeted genes identified less than 6 hours after inclusion (time frame: 6 hours after inclusion). 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 4 Mar 2024.