StrokeCONVASC-INCT04731584
Systemic Inflammation During Recanalization of Cerebral Arterial Occlusion
An observational study of Stroke and Systemic Infection, run by Hospices Civils de Lyon at 4 sites in France.
Trial summary
Strokes management, secondary to proximal arterial occlusion, by endovascular thrombectomy (TM) is now well established. The immuno-inflammatory events of reperfusion after TM are discussed. Systemic inflammation is a major factor suggested to explain the limited recovery of the ischemic parenchyma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Systemic Infection
- What is being tested?
- Blood sample
- How many people
- 15 participants
- Where
- 4 sitesFrance
- Study dates
- 7 Apr 2021to 12 Jun 2021
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients hospitalized for TM after a proximal ischemic stroke of the middle cerebral artery and whose reperfusion is satisfactory (TICI 2b, 2c and 3). Population of control patients, consisting of patients admitted on an outpatient basis for diagnostic cerebral arteriography.
Who may be able to join
- Adults patient (s)
- Ischemic stroke by occlusion of a middle cerebral artery (proximal portion M1)
- Initial diagnostic MRI infusion
- TM with complete reperfusion (TICI 2b, 2c or 3)
- TM performed under local anesthesia +/- anxiolysis, or sedation including propofol
- mRS prior to stroke <2
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- Barthel index <90
- Included in the HIBISCUS cohort
- Patient who was informed and did not object to participating in the study OR included through the emergency procedure then collection of his non-objection or that of his trusted person as soon as possible
- Adults patient (s)
- mRS <2
- Barthel index <90
- Requiring diagnostic arteriography for routine check-up of a cerebrovascular malformation
- Patient who was informed and did not object to participating in the study
Who cannot join
- NIHSS awareness score> or = 2
- Haemorrhagic complication before thrombectomy
- Pregnant woman
- Multiple vascular occlusions
- Occlusions of posterior or anterior cerebral territories other than M1
- Protected major
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- TM performed under general anesthesia
- Other vital failure than neurological failure
- GROUP "CONTROL" :
- NIHSS awareness score> or = 2
- Pregnant woman
- Protected major
- Exam performed under general anesthesia
Trial locations and contacts
4 sites in 1 country.
France4 sites
Service d'Anesthésie Réanimation Hôpital - Neurologique/Groupement Est
Bron, 69500
Service de Neurologie vasculaire - Hôpital Neurologique/Groupement Est
Bron, 69500
Service de Neuroradiologie interventionnelle - Hôpital Neurologique/Groupement Est
Bron, 69500
Service d'Anesthésie Réanimation - Hôpital Edouard Herriot/Groupement Centre
Lyon, 69437
About this study
Strokes management, secondary to proximal arterial occlusion, by endovascular thrombectomy (TM) is now well established. The immuno-inflammatory events of reperfusion after TM are discussed. Systemic inflammation is a major factor suggested to explain the limited recovery of the ischemic parenchyma. Understanding these phenomena is necessary before developing an immunomodulatory strategy.
- Conditions
- Stroke, Systemic Infection
- Being tested
- Blood sample
- Medical subject headings
- Stroke, Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
Patients from 2 groups will undergo blood sample (during a blood sample for there care) and inflammation parameters will be measure the day of the stroke
| Study group | Role | What they receive |
|---|---|---|
| AVC | Patients hospitalized for TM after a proximal ischemic stroke of the middle cerebral artery and whose reperfusion is satisfactory (TICI 2b, 2c and 3). Additional blood sample will be taken during usual treatment the day of the stroke. Receives: Biological: Blood sample | |
| Control | Population of control patients, consisting of patients admitted on an outpatient basis for a diagnostic cerebral arteriography. Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation parameters description
Inflammatory parameters such as CRP, IL-6, IL-10, HLA-DR, TNF-alpha, polymorphonuclear chemotaxis, CD-4, T-lymphocytes will be measure in blood sample
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start7 Apr 2021
- Primary completion12 Jun 2021
- Study completion12 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731584
- Sponsor's protocol ID
- 69HCL20_1080
- Acronym
- CONVASC-I
- Status last verified
- Feb 2023
- First submitted
- 26 Jan 2021
- Last updated
- 13 Feb 2023
- 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 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Inflammation During Recanalization of Cerebral Arterial Occlusion
- ClinicalTrials.gov ID
- NCT04731584
- Acronym / sponsor ID
- CONVASC-I / 69HCL20_1080
- Conditions
- Stroke, Systemic Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 12 Jun 2021 (actual)
- Study completion
- 12 Jun 2021 (actual)
- First posted
- 1 Feb 2021 (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.
Strokes management, secondary to proximal arterial occlusion, by endovascular thrombectomy (TM) is now well established. The immuno-inflammatory events of reperfusion after TM are discussed. Systemic inflammation is a major factor suggested to explain the limited recovery of the ischemic parenchyma. Understanding these phenomena is necessary before developing an immunomodulatory strategy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AVC | – | Biological: Blood samplePatients hospitalized for TM after a proximal ischemic stroke of the middle cerebral artery and whose reperfusion is satisfactory (TICI 2b, 2c and 3). Additional blood sample will be taken during usual treatment the day of the stroke. |
| Control | – | Biological: Blood samplePopulation of control patients, consisting of patients admitted on an outpatient basis for a diagnostic cerebral arteriography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for TM after a proximal ischemic stroke of the middle cerebral artery and whose reperfusion is satisfactory (TICI 2b, 2c and 3). Population of control patients, consisting of patients admitted on an outpatient basis for diagnostic cerebral arteriography.
Key inclusion criteria (14 listed)
- Adults patient (s)
- Ischemic stroke by occlusion of a middle cerebral artery (proximal portion M1)
- Initial diagnostic MRI infusion
- TM with complete reperfusion (TICI 2b, 2c or 3)
- TM performed under local anesthesia +/- anxiolysis, or sedation including propofol
Key exclusion criteria (13 listed)
- NIHSS awareness score> or = 2
- Haemorrhagic complication before thrombectomy
- Pregnant woman
- Multiple vascular occlusions
- Occlusions of posterior or anterior cerebral territories other than M1
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 samplePatients from 2 groups will undergo blood sample (during a blood sample for there care) and inflammation parameters will be measure the day of the stroke | Biological | AVC, Control |
Primary outcome
Inflammation parameters description
Time frame: 1 day
Inflammatory parameters such as CRP, IL-6, IL-10, HLA-DR, TNF-alpha, polymorphonuclear chemotaxis, CD-4, T-lymphocytes will be measure in blood sample
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 13 Feb 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Systemic Infection, run by Hospices Civils de Lyon at 4 sites 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 14 inclusion and 13 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 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Inflammation parameters description (time frame: 1 day). 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 13 Feb 2023.