Skip to main content
Clinical Trials/NCT06633809
NCT06633809
Recruiting
Not Applicable

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

Sir Run Run Shaw Hospital1 site in 1 country200 target enrollmentNovember 22, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke, Acute
Sponsor
Sir Run Run Shaw Hospital
Enrollment
200
Locations
1
Primary Endpoint
modified Rankin Scale at 90 days
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 22, 2021
End Date
March 1, 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jinhua Zhang

Prof.

Sir Run Run Shaw Hospital

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

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

Outcomes

Primary Outcomes

modified Rankin Scale at 90 days

Time Frame: 90 days

modified Rankin Scale at 90 days

acute neurological deterioration

Time Frame: 24 hours

It is neurological deterioration of presumed ischemic origin with an NIHSS score increase of 4 points or more within the 24 hours after onset.

Secondary Outcomes

  • Incidence of symptomatic intracerebral hemorrhage(2-3 days)
  • patients with good outcome comparing the two treatment groups(90 days)

Study Sites (1)

Loading locations...

Similar Trials