Acute Ichemic StrokeMISONCT04421326
Multimodal Investigation of Intracranial Clot Environment
An observational study of Acute Ichemic Stroke and Brain Ischemia, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Analysis of peri clot blood collected at the acute phase of stroke in order to understand physiopathological mechanisms involved in the cerebrovascular damage Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Ichemic Stroke, Brain Ischemia
- What is being tested?
- Analysis of the clot
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 14 Mar 2021to Oct 2025
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing Mechanical Thrombectomy for large vessel occclusion with acute ischemic stroke
Who may be able to join
- Over 18 years of age,
- Non-dependent for activities of daily living prior to the onset of the MI (Modified Rankin Score >2)
- Having an occlusion of a large arterial trunk proven by imaging (angio-MRI or angio-scanner).
Who cannot join
- Patients initially admitted but for whom endovascular treatment will not finally be performed (re-infusion, catheterization failure...) will be excluded from the study.
- Major patients under guardianship or curatorship or patients deprived of liberty
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital of Montpellier
Montpellier
Vincent COSTALAT, 0467337274, v-costalat@chu-montpellier.fr
About this study
Analysis of peri clot blood collected at the acute phase of stroke in order to understand physiopathological mechanisms involved in the cerebrovascular damage
Read the detailed description
It has been shown that immune cells accumulate around the clot at the acute phase of stroke. Leukocytes and their specific chemokines and cytokines regulation may impact cerebrovascular integrity.
- Conditions
- Acute Ichemic Stroke, Brain Ischemia
- Being tested
- Analysis of the clot
- Keywords
- Stroke, Blood Brain Barrier, Ischemia, Thrombus, Interventional Neuroradiology
- Medical subject headings
- Brain Ischemia, Stroke, Ischemia, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of the clotOther
Blood sampling at the site of intracranial occlusion during Mechanical Thrombectomy
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute ischemic stroke | Patients undergoing Mechanical Thrombectomy for large vessel occclusion with acute ischemic stroke Receives: Other: Analysis of the clot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metalloproteinase 9 quantification
Measured: 60 months
Metalloproteinase 2 quantification
Measured: 60 months
Secondary outcomes (1)
Cytokines levels
Proteomic analysis of cytokines IL-1β, TNF-α, IL-6
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start14 Mar 2021
- Primary completionJun 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ichemic StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Genomic Institute of Montpellier
- Responsible party
- Sponsor
- Investigators
- Vincent COSTALAT, MD PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421326
- Sponsor's protocol ID
- RECHMPL18_0236
- Acronym
- MISO
- Status last verified
- May 2024
- First submitted
- 28 May 2020
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Investigation of Intracranial Clot Environment
- ClinicalTrials.gov ID
- NCT04421326
- Acronym / sponsor ID
- MISO / RECHMPL18_0236
- Conditions
- Acute Ichemic Stroke, Brain Ischemia
- Keywords
- Stroke, Blood Brain Barrier, Ischemia, Thrombus, Interventional Neuroradiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Genomic Institute of Montpellier
- Study start
- 14 Mar 2021 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 9 Jun 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.
Analysis of peri clot blood collected at the acute phase of stroke in order to understand physiopathological mechanisms involved in the cerebrovascular damage
Detailed description
It has been shown that immune cells accumulate around the clot at the acute phase of stroke. Leukocytes and their specific chemokines and cytokines regulation may impact cerebrovascular integrity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute ischemic stroke | – | Other: Analysis of the clotPatients undergoing Mechanical Thrombectomy for large vessel occclusion with acute ischemic stroke |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing Mechanical Thrombectomy for large vessel occclusion with acute ischemic stroke
Key inclusion criteria (3 listed)
- Over 18 years of age,
- Non-dependent for activities of daily living prior to the onset of the MI (Modified Rankin Score >2)
- Having an occlusion of a large arterial trunk proven by imaging (angio-MRI or angio-scanner).
Key exclusion criteria (2 listed)
- Patients initially admitted but for whom endovascular treatment will not finally be performed (re-infusion, catheterization failure...) will be excluded from the study.
- Major patients under guardianship or curatorship or patients deprived of liberty
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 |
|---|---|---|
| Analysis of the clotBlood sampling at the site of intracranial occlusion during Mechanical Thrombectomy | Other | Patients with acute ischemic stroke |
Primary outcome
Metalloproteinase 9 quantification
Time frame: 60 months
Metalloproteinase 2 quantification
Time frame: 60 months
1 secondary outcome
Cytokines levels
Time frame: 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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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.
Vincent COSTALAT, MD PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ichemic Stroke and Brain Ischemia, run by University Hospital, Montpellier 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 2 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: status not confirmed, as of the sponsor's last update on 29 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cyril DARGAZANLI, MD MSc (467337532 ext. +33, c-dargazanli@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metalloproteinase 9 quantification (time frame: 60 months). The study lists 2 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 29 May 2024.