Endovascular treatmenT for Acute Ischemic Stroke in China (DETECT2-China)

Stroke, Ischemic Clinical Trial

Official title:

enDovascular trEatmenT for acutE isChemic sTroke in China (DETECT2-China): a Prospective, National, Multi-center, Registry Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05092139
• Other study ID #: y (2021) 077
• Status: Recruiting
• Start date: January 21, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a prospective real world registry study, aiming to explore the effectiveness and safety of endovascular treatment of acute ischemic stroke in a Chinese population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age: = 18;
• Ischemic stroke confirmed by head CT or MRI;
• Patients receiving endovascular treatment;
• First ever stroke or pre-stroke mRS=2;
• signed informed consent.

Exclusion Criteria:

• Prestroke mRS=3;
• Other serious illness that would confound the clinical outcome at 90 days;
• Unavailable neuroimaging data;
• Other unsuitable conditions judged by the investigator

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Device:
• endovascular treatment
all enrolled patients must receive endovascular treatment

Locations

Country	Name	City	State
China	Hui-Sheng Chen	ShenYang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	neuroimaging associated with clinical outcome	neuroimaging included brain CT, MRI or digital subtraction angiography	48 hours
Other	changes in serum biomarkers	biomarker included Matrix metalloproteinases, proinflammatory cytokines, and etc.	48 hours
Other	dynamic changes of TCD data associated	transcranial Doppler (TCD) data including blood velocity and pulse index, which will be collected at some centers	24 hours
Other	dynamic changes of cortical blood oxygen saturation by near infrared spectroscopy	The data will be collected at some centers	24 hours
Primary	Proportion of patients with modified Rankin Score 0 to 2	the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome	Day 90
Secondary	Proportion of patients with modified Rankin Score 0 to 1	the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome	Day 90
Secondary	Distribution of modified Rankin Score	the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome	Day 90
Secondary	Changes in National Institute of Health stroke scale (NIHSS)	the minimum and maximum values of NIHSS are 0 and 24, respectively; higher NIHSS mean a worse outcome	24 hours, 48 hours, and 2 weeks
Secondary	Proportion of symptomatic intracranial hemorrhage (sICH)	sICH was defined as 4 or more increase in NIHSS caused by hemorrhage	48 hours
Secondary	Proportion of death	death due to any cause	7 days