Stroke Registration of Young Adults in China

Ischemic Stroke Clinical Trial

— REACH  

Official title:

Stroke Registration of Young Adults in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03024164
• Other study ID #: REACH
• Status: Recruiting
• Start date: November 26, 2017
• Est. completion date: July 31, 2025

Study information

• Verified date: February 2024
• Source: The First Hospital of Jilin University
• Contact: Yi Yang, MD,PhD
• Phone: +86-18186870008
• Email: doctor_yangyi[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: July 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Other:
• Treatment following current guidelines
Treatment following current guidelines

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin

Sponsors (22)

Lead Sponsor

Collaborator

Yi Yang

Affilated Hospital of Inner Mongolia University for the Nationalities, Binzhou Medical University, Cangzhou Central Hospital, Chinese PLA General Hospital, Daqing Oilfieled General Hospital, Dezhou People's Hospital, First Affilated Hospital of Jiamusi University, Fudan University Pudong Medical Center, General Hospital of Ningxia Medical University, General Hospital of Shenyang Military Region, Heilongjiang Provicial Hospital, Inner Mongolia People's Hospital, Jiujiang No.1 People's Hospital, Luoyang Central Hospital Affilated to Zhengzhou University, Shaoxing People's Hospital, Siping Central People's Hospital, The Affiliated Hospital of Yanbian University, The First Affilated Hospital of the Medical College, Shihezi University, The First Affiliated Hospital of Soochow University, Wuzhou Red Cross Hospital, Xuchang Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke recurrence	Percentage of patients with the 1 year new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage)	1 year
Primary	Post-stroke disability	Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6 at 3-month follow-up.	3 months
Secondary	Cardiovascular death	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.	3 months, 6 months and 1 year
Secondary	Other cardiovascular event	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.	3 months, 6 months and 1 year
Secondary	Other systemic embolism	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.	3 months, 6 months and 1 year