Stroke Registration of Young Adults in China

Recruiting

• Conditions: Ischemic Stroke
• Interventions: Other: Treatment following current guidelines

• Registration Number: NCT03024164
• Lead Sponsor: Yi Yang

Brief Summary

This is a multi-center, prospective,continuous registry study. The investigators will include 3000 young adult (18-45 years old) patients with confirmed first-ever acute ischemic stroke in China. The main purpose of this study is to build the study cohort of young ischemic stroke patients in China, and to compare the prognosis and stroke recurrence of young patients with different ischemic stroke subtypes. Secondary objectives are trying to find biomarkers of stroke recurrence.

Detailed Description

Approximately 10%-14% of all ischemic strokes occur in young adults ages 18 to 45 years old. Stroke etiology in this population differs by geographic region and has greater heterogeneity than in older individuals. Ascertain the definite etiologic classification in this young patients might be the key point to prevent the stroke recurrence and reduce the stroke burden. Advances in stroke diagnostic tests, particularly neuroimaging, refinement in classification schema. In this multi-center registry study conducted in China, we determine to explore the difference of prognosis and stroke recurrence of young patients with different ischemic stroke subtypes.

Study Timeline

• Study First Submitted: 2017-01-15
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-18
• Study Start: 2017-11-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Age 18 through 45 years, both genders
• First-ever acute ischemic stroke
• Onset of symptoms within 72 hours of inclusion
• Willing to participate in follow-up visits

Exclusion Criteria

• Silent stroke
• Failure to give their informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Young adult stroke patients	Treatment following current guidelines	Young adult (18-45 years old) patients with confirmed first-ever acute ischemic stroke

Primary Outcome Measures

Name	Time	Method
Post-stroke disability	3 months	Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6 at 3-month follow-up.
Stroke recurrence	1 year	Percentage of patients with the 1 year new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage)

Secondary Outcome Measures

Name	Time	Method
Cardiovascular death	3 months, 6 months and 1 year	Percentage of patients with the 3-month, 6-month and 1 year cardiovascular death caused by any event of the following: Any stroke (ischemic or hemorrhage), sudden cardiac death, acute myocardial infarction, heart failure, and other cardiovascular death including pulmonary embolism, rupture of aortic aneurysm, cardiovascular interventional therapy, and peripheral arterial disease.
Other systemic embolism	3 months, 6 months and 1 year	Percentage of patients with the 3-month, 6-month and 1 year other systemic embolism except for cerebral artery, coronary artery, and pulmonary artery. Such as mesenteric arterial embolism,splenic artery embolization.
Other cardiovascular event	3 months, 6 months and 1 year	Percentage of patients with the 3-month, 6-month and 1 year other cardiovascular event including non-lethal myocardial infarction, and non fatal heart failure.

Trial Locations

Locations (1)

First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China