Early Neurological Deterioration in Patients With Acute Ischemic Stroke

• Conditions: Cerebral Infarction

• Registration Number: NCT03703986
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

This study set out to explore the risk factors of early neurological deterioration (END) occurred in patients with acute ischemic stroke and to investigate the corresponding predictors.

Detailed Description

END refers to the illness aggravation occurred in the early stage of stroke and often indicates a poor outcome. Some clinical scales may play an important role in its diagnoses and treatments. Across the reviewed studies, the risk factors of END, which included biochemical parameters, neuroimaging, ect. were explored incompletely and the effective predictors of END is unknown. We aimed to explore the risk factors of END and investigate the predictive value of certain scales.

Study Timeline

• Study First Submitted: 2018-06-26
• Study First Submitted QC: 2018-10-09
• Study First Posted: 2018-10-12
• Study Start: 2018-11-20
• Status Verified: 2019-01
• Primary Completion: 2019-01-25
• Study Completion: 2019-01-30
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Subjects with acute ischemic stroke
• Subjects with detailed progress notes

Exclusion Criteria

• Subjects with thrombolysis therapy
• Subjects with transient ischemia attach
• Subjects complicated with seriously underlying diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
National Institutes of Health Stroke Scale	7 days	National Institutes of Health Stroke Scale (NIHSS) can assess the severity of stroke. The total score of NIHSS ranges from 0 to 42, with higher scores indicating better neurological function.
Canadian Neurological Scale	7 days	Canadian Neurological Scale (CNS) can assess the severity of stroke as well. The total score of CNS ranges from 0 to 10, with higher scores indicating worse neurological function.

Secondary Outcome Measures

Name	Time	Method
Neuroimaging data	7days	Intracranial stenosis was defined as ≥ 50% narrowing in any of the intracranial arteries. Multi-vessel lesions were recorded when the number of cerebral vascular stenosis was greater than 2.
Blood parameters	7days	The blood parameters included total cholesterol, triglyceride, low-density lipoprotein and high-density lipoprotein. The normal range of them were 3 mmol·L-1 to 5.7 mmol·L-1, 0 mmol·L-1 to 2.25 mmol·L-1, 2.6 mmol·L-1 to 4.1 mmol·L-1, 1.03 mmol·L-1 to 1.55 mmol·L-1, respectively.

Trial Locations

Locations (1)

First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, China