NCT06595342

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60,000

participants targeted

Target at P75+ for all trials

Timeline
51mo left

Started Oct 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Oct 2024Jun 2030

First Submitted

Initial submission to the registry

September 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

October 30, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

1.7 years

First QC Date

September 10, 2024

Last Update Submit

October 1, 2024

Conditions

Keywords

Cervical Artery StenosisIntracranial Artery Stenosis

Outcome Measures

Primary Outcomes (1)

  • Incidence of stroke

    Incidence of stroke events including ischemic stroke, transient ischaemic attack and haemorrhagic stroke.

    One year

Secondary Outcomes (2)

  • Changes in the stenosis rate of cervical and intracranial arteries

    One year

  • Incidence of new clinical vascular events

    One year

Study Arms (1)

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

Interventions

no intervention

Patients with cervical/intracranial arteries stenosis

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Central Study Contacts

Yi Yang, MD,PhD

CONTACT

Zhen-Ni Guo, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The associate deam

Study Record Dates

First Submitted

September 10, 2024

First Posted

September 19, 2024

Study Start

October 30, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2030

Last Updated

October 3, 2024

Record last verified: 2024-10

Locations