- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04253275
Identification of Biomarkers in Ischemic Stroke - Clinical Trial (IBIS-CT)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Serge TIMSIT, Pr
- Phone Number: +33 298147349
- Email: serge.timsit@chu-brest.fr
Study Locations
-
-
-
Brest, France
- CHRU Brest
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- For ischemic stroke :
- Age > 18-year-old
- Ischemic stroke diagnosed on clinical presentation and cerebral imaging (CT or MRI imaging)
- Inclusion inferior to 6 hours from stroke onset
- 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
- For hemorragic stroke :
- Age > 18 year-old
- Hemorrhagic stroke diagnosed on clinical presentation and cerebral imaging (CT or MRI imaging)
- Inclusion inferior to 6 hours from stroke onset
- 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
Exclusion Criteria:
- 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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Ischemic stroke patients
Patients with ischemic stroke diagnosed on clinical presentation and cerebral imaging
|
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. |
Other: hemorragic stroke patients
Patients with hemorragic stroke diagnosed on clinical presentation and cerebral imaging
|
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. |
Other: healthy controls
Stroke-free
|
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 at inclusion for controls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
6 hours after inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RNA level expression across time according growth of infarction measured at inclusion and at 3 months
Time Frame: inclusion and 3 months
|
Each targeted genes will be measured by quantitative rt-PCR
|
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
|
Each targeted genes will be measured by quantitative rt-PCR
|
at 3 months
|
Targeted RNA level expression according mechanism of ischemic stroke
Time Frame: at 3 months
|
Each targeted RNA level expression of targeted genes will be measured by quantitative rt-PCR
|
at 3 months
|
Target RNA level expression in the saliva
Time Frame: at inclusion
|
For 3 participants, one of each arm, a saliva sample will be collected at inclusion.
|
at inclusion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Serge TIMSIT, Pr, serge.timsit@chu-brest.fr
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IBIS-CT (29BRC19.0268)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke, Ischemic
-
Nordsjaellands HospitalRigshospitalet, Denmark; Metropolitan University CollegeCompletedTransient Ischemic Attack | Stroke, Ischemic | Stroke HemorrhagicDenmark
-
University of CalgaryThe George Institute for Global Health, AustraliaNot yet recruitingAcute Ischemic Stroke AIS | Stroke, Acute, Stroke Ischemic | Stroke AcuteCanada, Australia
-
Second Affiliated Hospital, School of Medicine,...Shanghai Zhongshan Hospital; First Affiliated Hospital of Wenzhou Medical University and other collaboratorsRecruitingAcute Ischemic Stroke and Transient Ischemic AttacksChina
-
Medtronic Cardiac Rhythm and Heart FailureMedtronic Bakken Research CenterCompletedCryptogenic Symptomatic Transient Ischemic Attack | Cryptogenic Ischemic StrokeNetherlands, United States, France, Belgium, Germany, Sweden, Italy, Austria, Canada, Denmark, Finland, Greece, Slovakia, Spain
-
Umbria Bioengineering TechnologiesRecruitingStroke, Ischemic | Stroke HemorrhagicItaly
-
BayerRecruitingAcute Non-cardioembolic Ischemic Stroke | Prevention of Ischemic Stroke | High-risk Transient Ischemic AttackUnited States, Switzerland, Belgium, Australia, Sweden, Canada, Taiwan, Spain, Korea, Republic of, Latvia, Israel, Malaysia, China, Greece, Japan, Turkey, Netherlands, Romania, United Kingdom, Portugal, Hungary, Italy, Brazil, France, S... and more
-
Sheffield Teaching Hospitals NHS Foundation TrustUnknownFatigue | Stroke, Ischemic | Stroke HemorrhagicUnited Kingdom
-
University of AlbertaCompletedTransient Ischemic Attack | Minor Ischemic StrokeCanada
-
Stephanie HarrisonActive, not recruitingTransient Ischemic Attack | Stroke, IschemicUnited Kingdom
-
University of AlbertaCompletedTransient Ischemic Attack | Minor Ischemic StrokeCanada
Clinical Trials on blood samples
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Centre Hospitalier Universitaire de NīmesCompletedHenoch Schönlein PurpuraFrance
-
Centre Hospitalier Universitaire DijonCompletedPrimary Immune Thrombocytopenia (ITP)France
-
Institut BergoniéUnknown
-
Gustave Roussy, Cancer Campus, Grand ParisUnknownPaediatric MalignanciesFrance
-
Centre Georges Francois LeclercCompleted
-
Centre Hospitalier Universitaire DijonCompleted
-
University Hospital, BordeauxRecruitingSystemic Sclerosis | SclerodermaFrance
-
Centre Hospitalier Universitaire, AmiensCompleted
-
Assistance Publique Hopitaux De MarseilleRecruitingPlastic SurgeriesFrance