Acute Ischemic Stroke, Mild Neurocognitive Disorder, Thrombectomy
Conditions
Brief summary
Patients presenting with mild symptoms of acute ischemic stroke are common and account for approximately half of all acute ischemic stroke. About 30% of patients with minor stroke have a 90-day functional disability. Radiologically proven a large vessel occlusion (LVO) in patients with minor stroke is a well-established predictor of poor outcomes, while the poor outcomes following best medical management in patients with minor stroke with the underlying presence of a LVO are mainly driven by the occurrence of early neurological deterioration (END). Considering the well-known strong association between lack of arterial recanalization and END, endovascular therapy (EVT) appears as an attractive option to improve functional outcomes for LVO-related patients with stroke with mild symptoms. Whether EVT is safe and effective in patients with mild stroke with an LVO is currently debated, since these patients were typically excluded from the pivotal EVT trials. The current study aimed to further test the hypothesis that endovascular therapy would be superior to medical management with respect to functional recovery among low NIHSS patients caused by acute large-vessel occlusion in the anterior circulation.
Interventions
PROCEDUREEndovascular therapy
Drug: Best medical management All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate. Procedure: Endovascular therapy In the procedure, the methods including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty and stenting can be used according to the local interventionalists' choice. Mechanical thrombectomy or aspiration thrombectomy will be recommended as the primary treatment.
All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate.
Sponsors
First Affiliated Hospital of Wannan Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Drug: Best medical management Procedure: Endovascular therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years or older; 2. The time from onset of acute ischemic stroke to randomization is within 24 hours. Onset time is defined as the patient's Last Known Well (LKW); 3. Low NIHSS score (2-5 points), with at least one of the following items: 1. Altered mental status (lethargy or worse); 2. Facial palsy (facial weakness score ≥ 1 point); 3. Motor dysfunction (limb weakness score ≥ 1 point); 4. Aphasia (language disturbance score ≥ 1 point); 5. Hemispatial neglect (neglect score ≥ 1 point); 4. Intracranial internal carotid artery, proximal M1 or M2 segment of middle cerebral artery occlusion confirmed by cerebral CTA/MRA/DSA before randomization, which is identified as the culprit vessel for stroke; 5. All patients receive CTP/MR perfusion imaging, with a volume of perfusion delay (Tmax\>6 s) ≥ 50 mL; 6. Written informed consent is obtained from the patient or legal surrogate, with agreement for long-term follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90-day excellent clinical outcome | 90±7 days after randomization | modified Rankin scale score: 0-1; , 0 \[no disablility\] to 6 \[death\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of symptomatic intracranial hemorrhage (sICH) per Heidelberg standard | within 48 hours after randomization | Heidelberg standard was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item below: 4 points total NIHSS at the time of diagnosis compared to immediately before worsening. 2 point in one NIHSS category. Leading to intubation/hemicraniectomy/ventricular drainage placement or other major medical/surgical intervention. Absence of alternative explanation for deterioration. |
| All-cause mortality rate | 90±7 days after randomization | All-cause mortality rate |
| Good clinical outcome | 90±7 days after randomization | modified Rankin Scale score: 0-2; 0 \[no disablility\] to 6 \[death\] |
| 90-day ordinal modified Rankin Scale score shift | 90±7 days after randomization | ordinal modified Rankin Scale score shift; 0 \[no disablility\] to 6 \[death\] |
| Rates of early neurological deterioration | at 24 hours, 72 hours, and 7 days/discharge | early neurological deterioration during hospitalization |
| EuroQol Group 5- Dimension 5-Level (EQ-5D-5L) questionaire score | 90±7 days after randomization | Score range from -0.39 to 1.00, with higher scores indicating better quality of life |
Countries
China
Contacts
CONTACTZhiming Zhou, PhD
Outcome results
None listed