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

October 1, 2024 updated by: Yi Yang, The First Hospital of Jilin University
The aim of this study is to establish a prospective cohort of patients with cervical/intracranial arteries stenosis in China.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

60000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zhen-Ni Guo, MD, PhD
  • Phone Number: 0086 18186872986
  • Email: zhen1ni2@163.com

Study Contact Backup

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130000
        • First Hospital of Jilin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who were diagnosed with cervical artery stenosis and/or intracranial artery stenosis.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of stroke
Time Frame: One year
Incidence of stroke events including ischemic stroke, transient ischaemic attack and haemorrhagic stroke.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the stenosis rate of cervical and intracranial arteries
Time Frame: One year
The changes in the stenosis rate of cervical and intracranial arteries.
One year
Incidence of new clinical vascular events
Time Frame: 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.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 30, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

September 10, 2024

First Submitted That Met QC Criteria

September 10, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

October 3, 2024

Last Update Submitted That Met QC Criteria

October 1, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARTERIES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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