Cervical Artery StenosisNCT06595342
A Prospective Cohort of Patients With Cervical/Intracranial Arteries Stenosis in China
An observational study of Cervical Artery Stenosis and Intracranial Artery Stenosis, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
The aim of this study is to establish a prospective cohort of patients with cervical/intracranial arteries stenosis in China. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cervical Artery Stenosis, Intracranial Artery Stenosis
- How many people
- 60,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2024to 30 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were diagnosed with cervical artery stenosis and/or intracranial artery stenosis.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
First Hospital of Jilin University
Changchun, Jilin, 130000
Yi Yang, MD, PhD, 18186872986 ext. 0086, doctoryangyi@163.com
About this study
The aim of this study is to establish a prospective cohort of patients with cervical/intracranial arteries stenosis in China.
Read the 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.
- Being tested
- No intervention
- Keywords
- Cervical Artery Stenosis, Intracranial Artery Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of stroke
Incidence of stroke events including ischemic stroke, transient ischaemic attack and haemorrhagic stroke.
Measured: One year
Secondary outcomes (2)
Changes in the stenosis rate of cervical and intracranial arteries
The changes in the stenosis rate of cervical and intracranial arteries.
Measured: One year
Incidence of new clinical vascular events
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Oct 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Artery StenosisStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Yang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595342
- Sponsor's protocol ID
- ARTERIES
- Status last verified
- Oct 2024
- First submitted
- 10 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort of Patients With Cervical/Intracranial Arteries Stenosis in China
- ClinicalTrials.gov ID
- NCT06595342
- Acronym / sponsor ID
- ARTERIES
- Keywords
- Cervical Artery Stenosis, Intracranial Artery Stenosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60,000 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cervical/intracranial arteries stenosis | – | Other: No interventionInvestigators plan to enroll 60000 patients with cervical/intracranial arteries stenosis including mild stenosis, moderate stenosis, severe stenosis or occlusion. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were diagnosed with cervical artery stenosis and/or intracranial artery stenosis.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionno intervention | Other | Patients with cervical/intracranial arteries stenosis |
Primary outcome
Incidence of stroke
Time frame: One year
Incidence of stroke events including ischemic stroke, transient ischaemic attack and haemorrhagic stroke.
2 secondary outcomes
Changes in the stenosis rate of cervical and intracranial arteries
Time frame: One year
Incidence of new clinical vascular events
Time frame: One year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Artery Stenosis and Intracranial Artery Stenosis, run by The First Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Yang, MD,PhD (13756661217 ext. 0086, doctoryangyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of stroke (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.