Stroke Clinical Trial
— STARTOfficial title:
Strategy for Transfer to Emergency Head And Neck (UTEC) of Stroke Alerts With Suspicion of Large Vessel Occlusion for Mechanical Thrombectomy in the Languedoc Roussillon Region
NCT number | NCT04046757 |
Other study ID # | RECHMPL17_0378 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2019 |
Est. completion date | June 2022 |
A mono-centre observational study with the aim of compare clinical outcome at 3 month on patients admitted with recent cerebral infarct and intracranial large vessel occlusion in the anterior circulation who are eligible for mechanical thrombectomy in three different position : Patients admitted first in the Comprehensive Stroke Center of Montpellier, those transferred after Proximity Stroke Unit or prehospital bypass for patients with high suspicion of large vessel occlusion.to the Comprehensive Stroke Center of Montpellier
Status | Recruiting |
Enrollment | 1200 |
Est. completion date | June 2022 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: 1. Patient, admitted to the Emergency Department Head and Neck of the CHU de Montpellier, over 18 years old, without limit of upper age 2. With TIA or cerebral infarction (confirmed by brain imaging (MRI or CT scan), acute (Time of stroke symptoms or discovery of patient = 12 h) 3. With anterior circulation intracranial large vessel occlusion (M1, T or proximal M2), confirmed by arterial imaging (magnetic resonance angiography-MRA- or angioscanner) 4. No objection of the patient or their representative to being included in the cohort Exclusion Criteria: 1. Patient with severe intercurrent pathology impacting the short-term vital prognosis and making follow-up impossible 2. Predictable impossibility of patient follow-up |
Country | Name | City | State |
---|---|---|---|
France | Gui De Chauliac Hospital | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Modified Rankin Score (mRS) | Good functional outcome ( defined by a Modified Rankin Scale of 0-2, 3 months after stroke onset Modified Rankin scale . Range 0 (asymptomatic) to 6 (death)
Good outcome : 0 to 2 Disability : 3 to 5 Bad outcome : 5 and 6 |
3 months | |
Secondary | Incidence of mechanical thrombectomy treatment | Safety of medical complication
Complications of mechanical thrombectomy : Vessel perforation Intramural Arterial dissection Symptomatic Intracerebral hemorrhage embolization to a new territory |
24 hours | |
Secondary | Clinical evolution at 24 hours | NIHSS scale and NIHSS scale variation between the inclusion at 24 hours
National Institutes of Health Stroke Scale (NIHSS). Range 0-42. Neurological severity score at the acute phase : Minor stroke : 0 to 5 Moderate stroke 6 to 20 Severe stroke up to 21 |
24 hours | |
Secondary | Clinical evolution 7 days | NIHSS scale and NIHSS scale variation between the inclusion at 7 days
National Institutes of Health Stroke Scale (NIHSS). Range 0-42. Neurological severity score at the acute phase : Minor stroke : 0 to 5 Moderate stroke 6 to 20 Severe stroke up to 21 |
7 days | |
Secondary | Proportion of patients having had mechanical trombectomy (and/or intravenous thrombolysis) amongst patient cohort. | Number of patients having had mechanical trombectomy (and/or intravenous thrombolysis) amongst patient cohort. | 24 hours | |
Secondary | Symptomatic Intracerebral Haemorrhage | symptomatic Intracerebral Haemorrhage on cerebral imaging at 24 hours | 24 hours | |
Secondary | Arterial Recanalisation with TICI score | Quality of revascularization after mechanical thrombectomy : immediate post-Mechanical-Trombectomy evaluation for patient having had mechanical thrombectomy and at 24 hours for all patient cohort.
TICI score (Thrombolysis In Cerebral Infarction grading system) describe the quality of revascularization after mechanical thrombectomy (Grade 0 for no perfusion at 3 for Complete perfusion) |
post-act / 24 hours |
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