NCT05208203

Brief Summary

Acute ischemic stroke registry--Xuanwu Hospital(XSR) is an academic, independent, prospective, single center, observational registry study. Consecutive acute ischemic stroke patients assessed in stroke "green channel" of Xuanwu Hospital(China) will be enrolled in our study. Patients receive regular treatment and data will be collected as part of clinical routine. Baseline clinical and procedural information as well clinical follow-up information during in-hospital stay, and up to 90 days of stroke onset are collected. Data collected include demographics, National Institute of Health Stroke Scale (NIHSS) on admission, pre-treatment ASPECTS, information on timing and success of thrombolysis or thrombectomy, procedural complications, intracranial hemorrhage, and functional outcome.The study aim to investigate the real situation of assessment, diagnosis and treatment of acute ischemic stroke patients in "green channel",and verify the effect of the improvement of "green channel" process in the diagnosis and treatment of patients with acute ischemic stroke.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started May 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
May 2021Dec 2029

Study Start

First participant enrolled

May 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Expected
Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

1.7 years

First QC Date

January 12, 2022

Last Update Submit

January 12, 2022

Conditions

Acute Ischemic Stroke

Keywords

StrokeCerebrovascular disease

Outcome Measures

Primary Outcomes (1)

  • modified ranking scale on day (mRs) day 90

    mRs: modified ranking scale; the scale is a commonly used measurement for the degree of disability or dependence in the daily activities of people who have suffered a stroke; scale range 0-6, with 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms. 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.

    90 days

Secondary Outcomes (2)

  • Stroke Event

    1year

  • adverse event

    1year

Study Arms (1)

stroke patients

acute ischemic stroke patients including all treatments.

Other: telephone call d90

Interventions

telephone call d90OTHER

telephone call on day 90 to assess the primary outcome (mRs d90)

stroke patients

Eligibility Criteria

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

all acute stroke patients with the clinical diagnosis of acute ischemic stroke, Age \>18 years

You may qualify if:

  • Clinical diagnosis of acute ischemic stroke or transient ischemic attack(TIA)
  • Age \>18 years
  • Ethic approval in process
  • Receiving assessment in stroke "green channel" of Xuanwu Hospital

You may not qualify if:

  • Non-acute ischemic stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (3)

  • GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.

    PMID: 30879893BACKGROUND

  • Harris D, Hall C, Lobay K, McRae A, Monroe T, Perry JJ, Shearing A, Wollam G, Goddard T, Lang E. Canadian Association of Emergency Physicians position statement on acute ischemic stroke. CJEM. 2015 Mar;17(2):217-26. doi: 10.1017/cem.2015.26.

    PMID: 26120643BACKGROUND

  • van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988 May;19(5):604-7. doi: 10.1161/01.str.19.5.604.

    PMID: 3363593RESULT

MeSH Terms

Conditions

Ischemic StrokeStrokeCerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • qingfeng Ma, MD

    Xuanwu Hospital, Beijing

    STUDY CHAIR

Central Study Contacts

qingfeng Ma, MD

CONTACT

+8613601069493m.qingfeng@163.com

chuming Yan, MBBS

CONTACT

+8618810673782ycm19960214@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 12, 2022

First Posted

January 26, 2022

Study Start

May 1, 2021

Primary Completion

December 31, 2022

Study Completion (Estimated)

December 31, 2029

Last Updated

January 26, 2022

Record last verified: 2022-01

Locations

CN(1)