NCT03703986

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 12, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 20, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

2 months

First QC Date

June 26, 2018

Last Update Submit

January 30, 2019

Conditions

Keywords

deteriorationrisk factorspredictors

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Blood parameters

    7days

  • Neuroimaging data

    7days

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, China

RECRUITING

MeSH Terms

Conditions

Cerebral Infarction

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2018

First Posted

October 12, 2018

Study Start

November 20, 2018

Primary Completion

January 25, 2019

Study Completion

January 30, 2019

Last Updated

January 31, 2019

Record last verified: 2019-01

Locations