DETECT-China: Endovascular treatmenT for Acute Ischemic Stroke in China

• Sponsor: General Hospital of Shenyang Military Region (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04752735
• Collaborator: (none)
• Enrollment: 2,500
• Location: 1
• Anticipated Duration (Months): 21.3
• Patients Per Site Per Month: 117.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Endovascular Treatment	Other: endovascular treatment

Study Design

• Study Type: Observational
• Anticipated Enrollment: 2500 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Endovascular treatmenT for Acute Ischemic Stroke in China: a Retrospective, National, Multi-center, Registry Study
• Actual Study Start Date: Mar 22, 2021
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Outcome Measures

Primary Outcome Measures

1. Proportion of patients with modified Rankin Score (mRS) 0 to 2 [Day 90]

   the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome

Secondary Outcome Measures

1. Changes in National Institute of Health stroke scale (NIHSS) [Day 2, 7, 14]

   the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome

2. Proportion of patients with modified Rankin Score 0 to 2 [Day180, 360]

   Proportion of patients with modified Rankin Score 0 to 2

3. Distribution of modified Rankin Score [Day 90, 180, 360]

   Distribution of modified Rankin Score after treatment

4. Proportion of symptomatic intracranial hemorrhage (sICH) [48 hours]

   sICH was defined as 4 or more increase in NIHSS caused by hemorrhage

5. Proportion of intraparenchymal hemorrhage (PH1 and PH2) [48 hours]

   Proportion of intraparenchymal hemorrhage (PH1 and PH2) after treatment

6. Proportion of death [Day 7]

   death due to any cause

7. Changes in cerebral edema [48 hours, 7 days]

   edema is determined by middle shift.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurology, General Hospital of Northern Theater Command	Shenyang		China	110016

Sponsors and Collaborators

• General Hospital of Shenyang Military Region

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hui-Sheng Chen, Head of Neurology, General Hospital of Shenyang Military Region
• ClinicalTrials.gov Identifier: NCT04752735
• Other Study ID Numbers: y (2021)013
• First Posted: Feb 12, 2021
• Last Update Posted: Mar 15, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke; Ischemic Stroke

Study Results

No Results Posted as of Mar 15, 2022