Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Identification of Biomarkers in Ischemic Stroke - Clinical Trial (IBIS-CT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253275
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Tracking Information
First Submitted Date  ICMJE January 7, 2020
First Posted Date  ICMJE February 5, 2020
Last Update Posted Date February 5, 2020
Estimated Study Start Date  ICMJE April 2020
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2020)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2020)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Identification of Biomarkers in Ischemic Stroke - Clinical Trial
Official Title  ICMJE Identification of Biomarkers in Ischemic Stroke - Clinical Trial
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Stroke, Ischemic
  • Stroke Hemorrhagic
Intervention  ICMJE
  • Genetic: blood samples

    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.

  • Diagnostic Test: MRI without injection
    MRI at inclusion for controls
Study Arms  ICMJE
  • Ischemic stroke patients
    Patients with ischemic stroke diagnosed on clinical presentation and cerebral imaging
    Intervention: Genetic: blood samples
  • hemorragic stroke patients
    Patients with hemorragic stroke diagnosed on clinical presentation and cerebral imaging
    Intervention: Genetic: blood samples
  • healthy controls
    Stroke-free
    Interventions:
    • Genetic: blood samples
    • Diagnostic Test: MRI without injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Serge TIMSIT, Pr 298147349 ext +33 serge.timsit@chu-brest.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04253275
Other Study ID Numbers  ICMJE IBIS-CT (29BRC19.0268)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: Study Protocol
Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
Responsible Party University Hospital, Brest
Study Sponsor  ICMJE University Hospital, Brest
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Serge TIMSIT, Pr serge.timsit@chu-brest.fr
PRS Account University Hospital, Brest
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP