Early Neurological Deterioration in Patients With Acute Ischemic Stroke (ENDAIS)

January 30, 2019 updated by: The First Affiliated Hospital with Nanjing Medical University

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Nanjing, China
        • Recruiting
        • First Affiliated Hospital of Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients admitted to First Affiliated Hospital of Nangjing Medical University from January 2015 to April 2018 were collected retrospectively.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
END group
The patients in this group had an elevation of ≥ 2 points in the National Institute of Health Stroke Scale (NIHSS) within 7 days of stroke onset.
non-END group
The patients in this group had a slight increase of < 2 points or a decrease in NIHSS within 7 days of stroke onset.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Institutes of Health Stroke Scale
Time Frame: 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.
7 days
Canadian Neurological Scale
Time Frame: 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.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood parameters
Time Frame: 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.
7days
Neuroimaging data
Time Frame: 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.
7days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2018

Primary Completion (Actual)

January 25, 2019

Study Completion (Anticipated)

January 30, 2019

Study Registration Dates

First Submitted

June 26, 2018

First Submitted That Met QC Criteria

October 9, 2018

First Posted (Actual)

October 12, 2018

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-SR-099

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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