XuanwuH Acute Ischemic Stroke Registry

Acute Ischemic Stroke Clinical Trial

Official title:

Acute Ischemic Stroke "Green Channel" Registry--Xuanwu Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05208203
• Other study ID #: qingfeng ma stroke xuanwuH
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: December 31, 2029

Study information

• Verified date: January 2022
• Source: Xuanwu Hospital, Beijing
• Contact: qingfeng Ma, MD
• Phone: +8613601069493
• Email: m.qingfeng[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
China	Xuanwu Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

References & 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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Stroke Event	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
Secondary	adverse event	The patients were monitored whether they appeared symptomatic intracranial hemorrhage,cerebral hernia or other life-threatening events.	1year