Stroke Registration of Young Adults in China

NCT03024164 | Recruiting

• 1 other identifier: REACH
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

youth; etiology; prognosis; recurrence; biomarkers

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Cardiovascular death

  3 months, 6 months and 1 year

• Other cardiovascular event

  3 months, 6 months and 1 year

• Other systemic embolism

  3 months, 6 months and 1 year

Study Arms (1)

Young adult stroke patients

Young adult (18-45 years old) patients with confirmed first-ever acute ischemic stroke

Other: Treatment following current guidelines

Interventions

Treatment following current guidelines OTHER

Treatment following current guidelines

Young adult stroke patients

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Young adult patients who had their first-ever ischemic stroke symptoms within 72 hours and visited one of the 22 participating medical centers in People's Republic of China.

You may qualify if:

• Age 18 through 45 years, both genders
• First-ever acute ischemic stroke
• Willing to participate in follow-up visits

You may not qualify if:

• Silent stroke
• Failure to give their informed consent

Sponsors & Collaborators

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

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

EDTA-blood and serum will be collected for future analysis

MeSH Terms

Conditions

Ischemic Stroke; Recurrence

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yi Yang, MD,PhD

CONTACT

+86-18186870008; doctor_yangyi@hotmail.com

Zhenni Guo, MD

CONTACT

+86-18186872986; zhen1ni2@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate dean, Director of Cerebrovascular Disease Center

Study Record Dates

• First Submitted: January 15, 2017
• First Posted: January 18, 2017
• Study Start: November 26, 2017
• Primary Completion: December 31, 2024
• Study Completion: July 31, 2025
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)