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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Device: endovascular treatment

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

Study Locations

• China
  • Liaoning
    • ShenYang, Liaoning, China, 110840
      • Recruiting
      • Hui-Sheng Chen
      • Contact: Hui-Sheng Chen, Ph.D; Phone Number: +8624897511; Email: chszh@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

acute ischemic stroke with large vessel oclussion

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Proportion of symptomatic intracranial hemorrhage (sICH)	sICH was defined as 4 or more increase in NIHSS caused by hemorrhage	48 hours
Proportion of death	death due to any cause	7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
neuroimaging associated with clinical outcome	neuroimaging included brain CT, MRI or digital subtraction angiography	48 hours
changes in serum biomarkers	biomarker included Matrix metalloproteinases, proinflammatory cytokines, and etc.	48 hours
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
dynamic changes of cortical blood oxygen saturation by near infrared spectroscopy	The data will be collected at some centers	24 hours

Collaborators and Investigators

• Sponsor: General Hospital of Shenyang Military Region

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2022
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: y (2021) 077

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
• product manufactured in and exported from the U.S.: No