Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04916782 |
| Other study ID # |
RECHMPL19_0393 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 28, 2022 |
| Est. completion date |
October 2023 |
Study information
| Verified date |
February 2023 |
| Source |
University Hospital, Montpellier |
| Contact |
Cyril Dargazanli |
| Phone |
04.67.33.75.32 |
| Email |
c-dargazanli[@]chu-montpellier.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
