Menu
Recruiting NCT06633809

Therapy Evaluation in Patients With Minor Stroke and Large Vessel Occlusion

— Observational Stroke, Acute Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Immediate endovascular therapy.
Who it may be relevant to
Registry conditions: Stroke, Acute, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Therapy Evaluation in Patients With Minor Stroke and Large Vessel Occlusion: A Prospective Multicenter Registry Study

Overview

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.

Interventions

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

Primary outcome measures

  • modified Rankin Scale at 90 days [Time frame: 90 days]
  • acute neurological deterioration [Time frame: 24 hours]
Secondary outcome measures (2)
  • Incidence of symptomatic intracerebral hemorrhage [Time frame: 2-3 days]
  • patients with good outcome comparing the two treatment groups [Time frame: 90 days]

Eligibility criteria

Inclusion criteria

  • Aged 18 years or older
  • Acute ischemic stroke patients of NIHSS 0-5 with 24 hours after onset
  • Proximal intracranial artery occlusion on NCCT/CTA or MRI/MRA showing occlusion of the intracranial ICA, M1, or proximal M2 vessel
  • Baseline ASPECTS ≥6 or infarct Core Volume of < 70 on NCCT/DWI/CTP
  • Pre-mRS≤1

Exclusion criteria

  • Any sign of intracranial hemorrhage on baseline CT/MR;
  • Seizures at stroke onset
  • 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
  • Participation in any investigational study in the previous 30 days

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Sir Run Run Shaw Hospital — Hangzhou

Identifiers

NCT: NCT06633809 · 20210607-34

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗