Early Neurological Deterioration in Patients With Acute Ischemic Stroke

Cerebral Infarction Clinical Trial

— ENDAIS  

Official title:

Explore the Causes and Predictors of Early Neurological Deterioration Occurred in Patients With Acute Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03703986
• Other study ID #: 2014-SR-099
• Status: Recruiting
• Start date: November 20, 2018
• Est. completion date: January 30, 2019

Study information

• Verified date: January 2019
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Hong Cheng, MD
• Phone: +0086 2583674680
• Email: ch8706[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: January 30, 2019
• Est. primary completion date: January 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Locations

Country	Name	City	State
China	First Affiliated Hospital of Nanjing Medical University	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	National Institutes of Health Stroke Scale	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.	7 days
Primary	Canadian Neurological Scale	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.	7 days
Secondary	Blood parameters	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.	7days
Secondary	Neuroimaging data	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.	7days