Acute Ischemic StrokeEPICNCT04916782
Evaluation of Functional Recovery of Patients With Acute Ischemic Stroke Treated by Thrombectomy
An observational study of Acute Ischemic Stroke, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The management of cerebral infarctions (CI) is a real public health issue. The French National Authority for Health recommends Mechanical Thrombectomy (MT) either in combination with Intravenous Thrombolysis (IVT), or alone, after failure of IVT or in case of contraindication to IVT, within 6 hours of the onset of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Quality of life Questionnaire
- How many people
- 540 participants
- Where
- 1 siteFrance
- Study dates
- 28 Apr 2022to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with cerebral infarction treated in the acute phase by thrombectomy
Who may be able to join
- Age ≥ 18 years
- Indication for treatment with Mechanical Thrombectomy
- Imaging on admission (Scanner and/or Magnetic Resonance Imaging (MRI)) showing occlusion of a large intracranial artery intracranial artery (anterior, middle, posterior cerebral artery, basilar artery, vertebral vertebral artery)
- Health insurance coverage
- Obtaining the patient's consent
Who cannot join
- Patient with a serious intercurrent pathology impacting the vital prognosis in the short term and making it impossible to follow up at 3 months.
- Patients for whom follow-up will be impossible (foreign tourists)
- Patients of legal age (under guardianship, under curatorship, deprived of liberty)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital of Montpellier
Montpellier, 34295
Cyril DARGAZANLI, MD, 04 67 33 75 32 ext. 0033, c-dargazanli@chu-montpellier.fr
About this study
Official title: Evaluation of Favorable Functional Recovery Predictors at 3 Months of Patients With Acute Ischemic Stroke Treated by Mechanical Thrombectomy
The management of cerebral infarctions (CI) is a real public health issue. The French National Authority for Health recommends Mechanical Thrombectomy (MT) either in combination with Intravenous Thrombolysis (IVT), or alone, after failure of IVT or in case of contraindication to IVT, within 6 hours of the onset of symptoms.
The objective is to determine the factors predicting good functional recovery at 3 months in order to establish the typical profile of the "good responder" patient to MT and to evaluate functional recovery at 3 and 12 months (mRS ≤ 2) according to the modality of MT (depending on whether it is performed during the day or at night), the age of the patients, the equipment used for MT, the type of anaesthesia, as well as the impact of the metrics from the radiological evaluation in the patient's management. patient management.
Read the detailed description
The management of cerebral infarction (CI) is a real public health issue. There are 120,000 hospitalizations of CI patients per year in France. It is the leading cause of acquired disability and the second leading cause of dementia. Since 2015, the scientific community has demonstrated the benefits of mechanical thrombectomy (MT) in the treatment of patients with CI. The French National Authority for Health (HAS) recommends MT either in combination with intravenous (IV) thrombolysis, or alone, after failure of IV thrombolysis or in case of contraindication to IV thrombolysis, within 6 hours of the onset of symptoms.
Based on previous studies, the HAS has extended its recommendations for the treatment of patients (with occlusion of large vessels of the anterior cerebral circulation) whose onset of symptoms or last seen asymptomatic is between 6 and 16 hours, and may even extend up to 24 hours depending on strict inclusion criteria.
These previous clinical trials have shown the remarkable efficacy of MT in CI patients under the age of 80. There are no clear recommendations for MT in patients over 80 years of age, and further research is needed to improve the safety of MT.
Further research is needed to improve patient selection in the elderly. Today, predictive factors impacting on functional recovery such as age, blood glucose, and NIHSS neurological severity score have been evaluated. However, no association between these factors during the course of treatment has been established to determine the clinical and radiological characteristics that define the standard profile of "good responders" to MT.
The cohort is a continuation of the data previously collected in a database of the Commission Nationale de l'Informatique et des Libertés (CNIL). This database reports a complete follow-up (clinical, imaging and MT procedure data) of patients, from admission to 3 months after their hospitalisation. Some results have already been published.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Quality of life Questionnaire
- Keywords
- stroke, outcome, Thrombectomy
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life QuestionnaireOther
Quality of life questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Observational group | Not described Receives: Other: Quality of life Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the predictive factors of good functional recovery (modified Rankin Score (mRS) ≤ 2) at 3 months in order to establish the typical profile of the patient "good responder" to Mechanical Thrombectomy (MT)
Measured: At 3 months
Secondary outcomes (10)
Evaluate functional recovery at 3 months (mRS ≤ 2) according to the modality of MT (depending on whether it is carried out during the day or at night)
Measured: At 3 months
Evaluate functional recovery at 12 months (mRS ≤ 2) according to the modality of MT (depending on whether it is carried out during the day or at night)
Measured: At 12 months
Evaluate functional recovery at 12 months (mRS ≤ 2) according to the age of the patients, specifically for the very elderly (> 80 years old)
Measured: At 12 months
Evaluate functional recovery at 3 months (mRS ≤ 2) according to the age of the patients, specifically for the very elderly (> 80 years old)
Measured: At 3 months
Evaluate functional recovery at 3 months (mRS ≤ 2) according to material used for MT
Measured: At 3 months
Evaluate functional recovery at 12 months (mRS ≤ 2) according to material used for MT
Measured: At 12 months
Evaluate functional recovery at 12 months (mRS ≤ 2) according to the type of anesthesia (conscious sedation / general anesthesia)
Measured: At 12 months
Evaluate functional recovery at 3 months (mRS ≤ 2) according to the type of anesthesia (conscious sedation / general anesthesia)
Measured: At 3 months
Evaluate functional recovery at 3 months (mRS ≤ 2) according to the impact of metrics from the radiological assessment in patient care
Measured: At 3 months
Evaluate functional recovery at 12 months (mRS ≤ 2) according to the impact of metrics from the radiological assessment in patient care
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start28 Apr 2022
- Primary completionOct 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 Ischemic 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
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916782
- Sponsor's protocol ID
- RECHMPL19_0393
- Acronym
- EPIC
- Status last verified
- May 2024
- First submitted
- 1 Jun 2021
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Favorable Functional Recovery Predictors at 3 Months of Patients With Acute Ischemic Stroke Treated by Mechanical Thrombectomy
- ClinicalTrials.gov ID
- NCT04916782
- Acronym / sponsor ID
- EPIC / RECHMPL19_0393
- Conditions
- Acute Ischemic Stroke
- Keywords
- stroke, outcome, Thrombectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 8 Jun 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.
The management of cerebral infarctions (CI) is a real public health issue. The French National Authority for Health recommends Mechanical Thrombectomy (MT) either in combination with Intravenous Thrombolysis (IVT), or alone, after failure of IVT or in case of contraindication to IVT, within 6 hours of the onset of symptoms.
The objective is to determine the factors predicting good functional recovery at 3 months in order to establish the typical profile of the "good responder" patient to MT and to evaluate functional recovery at 3 and 12 months (mRS ≤ 2) according to the modality of MT (depending on whether it is performed during the day or at night), the age of the patients, the equipment used for MT, the type of anaesthesia, as well as the impact of the metrics from the radiological evaluation in the patient's management. patient management.
Detailed description
The management of cerebral infarction (CI) is a real public health issue. There are 120,000 hospitalizations of CI patients per year in France. It is the leading cause of acquired disability and the second leading cause of dementia. Since 2015, the scientific community has demonstrated the benefits of mechanical thrombectomy (MT) in the treatment of patients with CI. The French National Authority for Health (HAS) recommends MT either in combination with intravenous (IV) thrombolysis, or alone, after failure of IV thrombolysis or in case of contraindication to IV thrombolysis, within 6 hours of the onset of symptoms.
Based on previous studies, the HAS has extended its recommendations for the treatment of patients (with occlusion of large vessels of the anterior cerebral circulation) whose onset of symptoms or last seen asymptomatic is between 6 and 16 hours, and may even extend up to 24 hours depending on strict inclusion criteria.
These previous clinical trials have shown the remarkable efficacy of MT in CI patients under the age of 80. There are no clear recommendations for MT in patients over 80 years of age, and further research is needed to improve the safety of MT.
Further research is needed to improve patient selection in the elderly. Today, predictive factors impacting on functional recovery such as age, blood glucose, and NIHSS neurological severity score have been evaluated. However, no association between these factors during the course of treatment has been established to determine the clinical and radiological characteristics that define the standard profile of "good responders" to MT.
The cohort is a continuation of the data previously collected in a database of the Commission Nationale de l'Informatique et des Libertés (CNIL). This database reports a complete follow-up (clinical, imaging and MT procedure data) of patients, from admission to 3 months after their hospitalisation. Some results have already been published.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Other: Quality of life Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with cerebral infarction treated in the acute phase by thrombectomy
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Indication for treatment with Mechanical Thrombectomy
- Imaging on admission (Scanner and/or Magnetic Resonance Imaging (MRI)) showing occlusion of a large intracranial artery intracranial artery (anterior, middle, posterior cerebral artery, basilar artery, vertebral vertebral artery)
- Health insurance coverage
- Obtaining the patient's consent
Key exclusion criteria (3 listed)
- Patient with a serious intercurrent pathology impacting the vital prognosis in the short term and making it impossible to follow up at 3 months.
- Patients for whom follow-up will be impossible (foreign tourists)
- Patients of legal age (under guardianship, under curatorship, 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 |
|---|---|---|
| Quality of life QuestionnaireQuality of life questionnaire | Other | Observational group |
Primary outcome
Determine the predictive factors of good functional recovery (modified Rankin Score (mRS) ≤ 2) at 3 months in order to establish the typical profile of the patient "good responder" to Mechanical Thrombectomy (MT)
Time frame: At 3 months
10 secondary outcomes
Evaluate functional recovery at 3 months (mRS ≤ 2) according to the modality of MT (depending on whether it is carried out during the day or at night)
Time frame: At 3 months
Evaluate functional recovery at 12 months (mRS ≤ 2) according to the modality of MT (depending on whether it is carried out during the day or at night)
Time frame: At 12 months
Evaluate functional recovery at 12 months (mRS ≤ 2) according to the age of the patients, specifically for the very elderly (> 80 years old)
Time frame: At 12 months
Evaluate functional recovery at 3 months (mRS ≤ 2) according to the age of the patients, specifically for the very elderly (> 80 years old)
Time frame: At 3 months
Evaluate functional recovery at 3 months (mRS ≤ 2) according to material used for MT
Time frame: At 3 months
Evaluate functional recovery at 12 months (mRS ≤ 2) according to material used for MT
Time frame: At 12 months
Evaluate functional recovery at 12 months (mRS ≤ 2) according to the type of anesthesia (conscious sedation / general anesthesia)
Time frame: At 12 months
Evaluate functional recovery at 3 months (mRS ≤ 2) according to the type of anesthesia (conscious sedation / general anesthesia)
Time frame: At 3 months
Evaluate functional recovery at 3 months (mRS ≤ 2) according to the impact of metrics from the radiological assessment in patient care
Time frame: At 3 months
Evaluate functional recovery at 12 months (mRS ≤ 2) according to the impact of metrics from the radiological assessment in patient care
Time frame: At 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
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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.
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 Ischemic Stroke, 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 5 inclusion and 3 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 28 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 (04.67.33.75.32 ext. 0033, 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?
Determine the predictive factors of good functional recovery (modified Rankin Score (mRS) ≤ 2) at 3 months in order to establish the typical profile of the patient "good responder" to Mechanical Thrombectomy (MT) (time frame: At 3 months). 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 28 May 2024.