- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05208203
XuanwuH Acute Ischemic Stroke Registry
January 12, 2022 updated by: qingfengma, Xuanwu Hospital, Beijing
Acute Ischemic Stroke "Green Channel" Registry--Xuanwu Hospital
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
500
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
- Name: Qingfeng Ma, MD
- Phone Number: +8613601069493
- Email: m.qingfeng@163.com
Study Contact Backup
- Name: chuming Yan, MBBS
- Phone Number: +8618810673782
- Email: ycm19960214@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100053
- Recruiting
- Xuanwu Hospital
-
Contact:
- Qingfeng Ma, MD
- Phone Number: +8613601069493
- Email: m.qingfeng@163.com
-
-
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
Non-Probability Sample
Study Population
all acute stroke patients with the clinical diagnosis of acute ischemic stroke, Age >18 years
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Non-acute ischemic stroke
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
stroke patients
acute ischemic stroke patients including all treatments.
|
telephone call on day 90 to assess the primary outcome (mRs d90)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
modified ranking scale on day (mRs) day 90
Time Frame: 90 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stroke Event
Time Frame: 1year
|
The patients were monitored whether they recured ischemic stroke event including transient ischemic attack (TIA) or stroke confirmed by neurologist and diffusion-weighted image MRI.
|
1year
|
|
adverse event
Time Frame: 1year
|
The patients were monitored whether they appeared symptomatic intracranial hemorrhage,cerebral hernia or other life-threatening events.
|
1year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Qingfeng Ma, MD, Xuanwu Hospital, Beijing
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
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)
May 1, 2021
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2029
Study Registration Dates
First Submitted
January 12, 2022
First Submitted That Met QC Criteria
January 12, 2022
First Posted (Actual)
January 26, 2022
Study Record Updates
Last Update Posted (Actual)
January 26, 2022
Last Update Submitted That Met QC Criteria
January 12, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- qingfeng ma stroke xuanwuH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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