Therapy Evaluation in Patients With Minor Stroke and Large Vessel Occlusion

NCT ID: NCT06633809

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-22
• Study Completion Date: 2027-03-01

Brief Summary

This multicenter registry study, which record the therapy strategy and follows up these acute ischemic stroke (AIS) patients with low NIHSS and large vessel occlusion (LVO), is intended to provide the important data for therapy evaluation and prognostic prediction of the LVO patients with low NIHSS.

Detailed Description

It was reported that about two third of the stoke patients might present with minor or mild stroke symptoms. 20-40% of those minor stroke patients had large vessel occlusion (LVO). AIS patients with LVO and low NIHSS are common and has been associated with early neurological deterioration and worse outcomes. Until now, the best therapy strategy for the acute stoke patients with minor stroke and large vessel occlusion is unknown. Thus, we sought to (1) explore the potential predictors of acute neurological deterioration and 90-day clinical outcome; (2) and evaluate the best therapy strategy.

Conditions

Stroke, Acute; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Brain Infarction; Nervous System Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Immediate Endovascular Therapy

The immediate endovascular therapy is performed immediately after stroke onset with any thrombectomy device usually used.

Immediate endovascular therapy

Intervention Type: OTHER

The best medical therapy includes intravenous fibrinolysis, anticoagulants or antiplatelet, but NOT any immediate endovascular therapies.

Best Medical Therapy

The best medical therapy is standard medical therapy, including intravenous fibrinolysis, anticoagulants or antiplatelet, but NOT including any endovascular therapies. The rescue endovascular therapies may be performed in case of acute neurological deterioration.

No interventions assigned to this group

Interventions

Immediate endovascular therapy

The best medical therapy includes intravenous fibrinolysis, anticoagulants or antiplatelet, but NOT any immediate endovascular therapies.

Intervention Type: OTHER

Other Intervention Names

Best medical therapy

Eligibility Criteria

Inclusion Criteria

1. Aged 18 years or older

2. Acute ischemic stroke patients of NIHSS 0-5 with 24 hours after onset

3. Proximal intracranial artery occlusion on NCCT/CTA or MRI/MRA showing occlusion of the intracranial ICA, M1, or proximal M2 vessel

4. Baseline ASPECTS ≥6 or infarct Core Volume of < 70 on NCCT/DWI/CTP

5. Pre-mRS≤1

Exclusion Criteria

1. Any sign of intracranial hemorrhage on baseline CT/MR;

2. Seizures at stroke onset

3. Baseline blood glucose of <2.78 mmol or >22.20 mmol, or platelet count < 100,000/uL or serum creatinine levels > 3.0 mg/dL

4. Participation in any investigational study in the previous 30 days

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jinhua Zhang

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Xingyue Hu, Prof.

Role: primary

huxingyue2003@zju.edu.cn

8657186006902 ext. 8657186006902

Other Identifiers

20210607-34

Identifier Type: -

Identifier Source: org_study_id