Stroke Clinical Trial
— DETECT-ChinaOfficial title:
Endovascular treatmenT for Acute Ischemic Stroke in China: a Retrospective, National, Multi-center, Registry Study
NCT number | NCT04752735 |
Other study ID # | y (2021)013 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 22, 2021 |
Est. completion date | February 8, 2023 |
Verified date | February 2023 |
Source | General Hospital of Shenyang Military Region |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a retrospective real world registry study, aiming to explore the effectiveness and safety of endovascular treatment of acute ischemic stroke in a Chinese population.
Status | Completed |
Enrollment | 1000 |
Est. completion date | February 8, 2023 |
Est. primary completion date | February 8, 2023 |
Accepts healthy volunteers | |
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 mRS=2 after previous disease; - Complete and clear pre- and post-operative DSA images are available Exclusion Criteria: - Imaging data not qualified for evaluation; - Absence of important clinical data; - The first 50 patients receiving endovascular treatment in a single centerr. |
Country | Name | City | State |
---|---|---|---|
China | Department of Neurology, General Hospital of Northern Theater Command | Shenyang |
Lead Sponsor | Collaborator |
---|---|
General Hospital of Shenyang Military Region |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with modified Rankin Score (mRS) 0 to 2 | the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS 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 42, respectively; higher NIHSS mean a worse outcome | Day 2, 7, 14 | |
Secondary | Proportion of patients with modified Rankin Score 0 to 2 | Proportion of patients with modified Rankin Score 0 to 2 | Day180, 360 | |
Secondary | Distribution of modified Rankin Score | Distribution of modified Rankin Score after treatment | Day 90, 180, 360 | |
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 intraparenchymal hemorrhage (PH1 and PH2) | Proportion of intraparenchymal hemorrhage (PH1 and PH2) after treatment | 48 hours | |
Secondary | Proportion of death | death due to any cause | Day 7 | |
Secondary | Changes in cerebral edema | edema is determined by middle shift. | 48 hours, 7 days |
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