Internal Carotid Artery StenosisNCT05260229
The Observation About the Effects of Internal Carotid Artery Stenosis on Fundus Vessels and the Changes of Fundus Vessels After Interventional Therapy
An observational study of Internal Carotid Artery Stenosis, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The investigators plan to collect 30 participants with internal carotid artery stenosis to observed the relationship between the degree of internal carotid artery stenosis and fundus vessels （and blood flow）density before operation, and compared with participants without internal carotid artery stenosis.The fundus… Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Internal Carotid Artery Stenosis
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2021to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have been diagnosed with carotid artery stenosis and need surgery.
Who may be able to join
- Patients who have been diagnosed with carotid artery stenosis and need surgery;
- Patients whose vision won't get worse soon;
- Patients have not had any eye surgeries;
- Patients with complete profile.
Who cannot join
- Patients with severe systemic disease;
- Patients with poor dioptric stroma;
- Patients with nystagmus;
- Patients with incomplete profile.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of ophthalmology and neurology at Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Xuepeng Yang, undergrad, （+86）15628762662, 2420930410@qq.com
About this study
The investigators plan to collect 30 participants with internal carotid artery stenosis to observed the relationship between the degree of internal carotid artery stenosis and fundus vessels （and blood flow）density before operation, and compared with participants without internal carotid artery stenosis.The fundus blood flow density will be observed after intervention operation in order to see whether the operation is effective to improve the density of fundus vessels and blood flow or not.
- Conditions
- Internal Carotid Artery Stenosis
- Medical subject headings
- Carotid Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
The differences of perfusion density in the Forum of the optical coherence tomography angiography（OCTA ）of Zeiss Company
The perfusion density differences between the fundus vessels（both the macula area and the optic disc area） on the carotid artery stenosis side and the not-significant narrowing side，or the perfusion density differences between the fundus vessels（both the macula area and the optic disc area） on the carotid artery stenosis side and the side with carotid artery stenosis of different degrees.
Measured: 2022-01-31
The differences of perfusion density in the Forum of the optical coherence tomography angiography（OCTA ）of Zeiss Company
The perfusion density differences between the fundus vessels on the carotid artery stenosis side and the same side after interventional surgery.
Measured: 2022-02-14
The differences of vessel density in the Forum of the optical coherence tomography angiography（OCTA ）of Zeiss Company
The vessel density differences between the fundus vessels（both the macula area and the optic disc area） on the carotid artery stenosis side and the not-significant narrowing side，or the vessel density differences between the fundus vessels（both the macula area and the optic disc area） on the carotid artery stenosis side and the side with carotid artery stenosis of different degrees.
Measured: 2022-01-31
The differences of vessel density in the Forum of the optical coherence tomography angiography（OCTA ）of Zeiss Company
The vessel density differences between the fundus vessels on the carotid artery stenosis side and the same side after interventional surgery.
Measured: 2022-02-14
The perimeter and area of the fovea avascular zone（FAZ）in the Forum of the optical coherence tomography angiography（OCTA ）of Zeiss Company
The differences between the perimeter and area of the fovea avascular zone（FAZ） of the carotid artery stenosis side before and after interventional surgery.
Measured: 2022-02-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start12 Dec 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internal Carotid Artery StenosisStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260229
- Sponsor's protocol ID
- cuiyanqiluteam
- Status last verified
- Oct 2021
- First submitted
- 14 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Observation About the Effects of Internal Carotid Artery Stenosis on Fundus Vessels and the Changes of Fundus Vessels After Interventional Therapy
- ClinicalTrials.gov ID
- NCT05260229
- Acronym / sponsor ID
- cuiyanqiluteam
- Conditions
- Internal Carotid Artery Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 12 Dec 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 2 Mar 2022 (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 investigators plan to collect 30 participants with internal carotid artery stenosis to observed the relationship between the degree of internal carotid artery stenosis and fundus vessels （and blood flow）density before operation, and compared with participants without internal carotid artery stenosis.The fundus blood flow density will be observed after intervention operation in order to see whether the operation is effective to improve the density of fundus vessels and blood flow or not.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been diagnosed with carotid artery stenosis and need surgery.
Key inclusion criteria (4 listed)
- Patients who have been diagnosed with carotid artery stenosis and need surgery;
- Patients whose vision won't get worse soon;
- Patients have not had any eye surgeries;
- Patients with complete profile.
Key exclusion criteria (4 listed)
- Patients with severe systemic disease;
- Patients with poor dioptric stroma;
- Patients with nystagmus;
- Patients with incomplete profile.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The differences of perfusion density in the Forum of the optical coherence tomography angiography（OCTA ）of Zeiss Company
Time frame: 2022-01-31
The perfusion density differences between the fundus vessels（both the macula area and the optic disc area） on the carotid artery stenosis side and the not-significant narrowing side，or the perfusion density differences between the fundus vessels（both the macula area and the optic disc area） on the carotid artery stenosis side and the side with carotid artery stenosis of different degrees.
The differences of perfusion density in the Forum of the optical coherence tomography angiography（OCTA ）of Zeiss Company
Time frame: 2022-02-14
The perfusion density differences between the fundus vessels on the carotid artery stenosis side and the same side after interventional surgery.
The differences of vessel density in the Forum of the optical coherence tomography angiography（OCTA ）of Zeiss Company
Time frame: 2022-01-31
The vessel density differences between the fundus vessels（both the macula area and the optic disc area） on the carotid artery stenosis side and the not-significant narrowing side，or the vessel density differences between the fundus vessels（both the macula area and the optic disc area） on the carotid artery stenosis side and the side with carotid artery stenosis of different degrees.
The differences of vessel density in the Forum of the optical coherence tomography angiography（OCTA ）of Zeiss Company
Time frame: 2022-02-14
The vessel density differences between the fundus vessels on the carotid artery stenosis side and the same side after interventional surgery.
The perimeter and area of the fovea avascular zone（FAZ）in the Forum of the optical coherence tomography angiography（OCTA ）of Zeiss Company
Time frame: 2022-02-14
The differences between the perimeter and area of the fovea avascular zone（FAZ） of the carotid artery stenosis side before and after interventional surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
Related trials for Internal Carotid Artery Stenosis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Safety and Efficacy of Carotid Artery Stenting Combined With Intermittent Hypoxia Intervention in Patients With Severe Internal Carotid Artery Stenosis
Internal Carotid Artery Stenosis
Recruiting
Endovascular Acute Stroke Intervention - Tandem OCclusion Trial
Stroke, Acute, Carotid Stenosis
Recruiting
Transcranial Doppler for Internal Carotid Artery Stenting (TCD-ICAS)
Artery Stenosis
RecruitingPhase 2/3
Role of GLP1 RA Dulaglutide on Severe Intracranial Atherosclerosis
Intracranial Atherosclerosis, Stroke, Ischemic
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. This study is not recruiting at the moment.
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 Internal Carotid Artery Stenosis, run by Qilu Hospital of Shandong 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Cui, doctor (（+86）18560088136, cyeleanor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The differences of perfusion density in the Forum of the optical coherence tomography angiography（OCTA ）of Zeiss Company (time frame: 2022-01-31). The study lists 5 primary outcomes in all. 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 2 Mar 2022.