A Prospective Cohort of Patients With Cervical/Intracranial Arteries Stenosis in China

Not yet recruiting

• Conditions: Cervical Artery Stenosis; Intracranial Artery Stenosis
• Interventions: Other: No intervention

• Registration Number: NCT06595342
• Lead Sponsor: The First Hospital of Jilin University

Brief Summary

The aim of this study is to establish a prospective cohort of patients with cervical/intracranial arteries stenosis in China.

Detailed Description

A prospective cohort of patients with cervical/intracranial arteries stenosis from various regions of China will be established. This prospective cohort is used to identify the distribution of risk factors in the patients with cervical/intracranial arteries stenosis.

Study Timeline

• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-10
• Study First Posted: 2024-09-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Study Start: 2024-10-30
• Primary Completion: 2026-06-30
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60000

Inclusion Criteria

1. Age ≥ 40 and ≤ 80 years;
2. Ultrasound or imaging examinations indicating cervical artery stenosis and/or intracranial artery stenosis (including mild, moderate, severe stenosis, or occlusion);
3. Willing to participate and signing the informed consent form.

Exclusion Criteria

1. Patients with stroke occurring within the past year;
2. Patients with severe systemic diseases, such as respiratory failure, renal failure, gastrointestinal bleeding, coagulation disorders, malignancies, etc.;
3. Patients with a life expectancy of less than one year or those who are unable to complete the study for other reasons.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with cervical/intracranial arteries stenosis	No intervention	Investigators plan to enroll 60000 patients with cervical/intracranial arteries stenosis including mild stenosis, moderate stenosis, severe stenosis or occlusion.

Primary Outcome Measures

Name	Time	Method
Incidence of stroke	One year	Incidence of stroke events including ischemic stroke, transient ischaemic attack and haemorrhagic stroke.

Secondary Outcome Measures

Name	Time	Method
Changes in the stenosis rate of cervical and intracranial arteries	One year	The changes in the stenosis rate of cervical and intracranial arteries.
Incidence of new clinical vascular events	One year	Incidence of new clinical vascular events (ischemic stroke/ hemorrhagic stroke/ transient ischemic stroke/ myocardial infarction/ vascular death) as a cluster and evaluated individually. Vascular death was defined as death due to stroke (ischemic or hemorrhagic), systemic hemorrhage, myocardial infarction, congestive heart failure, pulmonary embolism, sudden death, or arrhythmia.

Trial Locations

Locations (1)

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