Therapy Evaluation in Patients With Minor Stroke and Large Vessel Occlusion (TEMPOS)

Zhejiang University

Status: Enrolling

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

Treatments: Other: Immediate endovascular therapy

Study type: Observational

Funder types: Other

Identifiers

NCT06633809

20210607-34

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Immediate Endovascular Therapy

Description:

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

Treatment:

Other: Immediate endovascular therapy

Best Medical Therapy

Description:

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.