Carotid StenosisNCT04326842

Optical Coherence Tomography Angiography Evaluation of Ocular Changes in Patients With Carotid Artery Stenosis

An observational study of Carotid Stenosis, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for: Carotid Stenosis
What is being tested?: Carotid artery revascularization procedure and Optical coherence tomography angiography
Type of treatment: Medical device, Surgery or procedure
How many people: 129 participants
Where: 1 siteChina
Study dates: 2 Apr 2020to 2 Jul 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 100 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Participants with carotid artery stenosis undergoing cerebral and eye examination and in routine clinical practice will be included

Who may be able to join

Clinical diagnosis of carotid artery stenosis
Age-gender-race-matched controls

Who cannot join

age <18 years
intraocular pressure (IOP) >21 mmHg
VA >logMAR 1.0
spherical equivalent (SE) between >1.00 or < -6.00 D
other serious eye diseases which may affect OCTA results including diabetic retinopathy, hypertensive retinopathy, retinal vascular occlusion, age-related macular degeneration, and uveitis
major intraocular surgery performed in the past 6 months or a history of laser photocoagulation or intravitreal injection
glaucoma or first-degree relatives with a history of glaucoma; and
any disease that might cause poor scan quality (image quality <6).

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang

Other trials in China

About this study

This study aims to evaluate ocular changes in patients with carotid artery stenosis by optical coherence tomography angiography before and after carotid artery revascularization procedure.

Read the detailed description

A growing body of research indicates that abnormal ocular microvascular features may serve as a novel biomarker reflecting the severity of underlying cardiovascular, neurodegenerative, and microvascular disease. Since blood flow to the retina is predominantly supplied by the internal carotid artery (ICA), we hypothesized that ocular microvasculature and structure changes may reflect the disease status or therapeutic effects in patients with carotid artery stenosis.

Optical coherence tomography angiography (OCTA) is a novel, non-invasive imaging modality that can be a reliable tool for the qualitative and quantitative assessments of ocular vessels during various ocular pathological or physiological changes. Recent studies have also demonstrated the ability of OCTA to quantify retinal microvascular changes in monitoring cardiovascular risk.

This study aims to evaluate ocular changes in patients with carotid artery stenosis by optical coherence tomography angiography before and after carotid artery revascularization procedure.In this study, the patients with carotid artery stenosis and control group will receive a series of cerebral and ocular examinations including the most important cerebral CT perfusion (CTP) and OCTA. After that, the cerebral and ocular data between the two groups will be compared. Also, the preoperative and postoperative data acquired will be compared.

Conditions: Carotid Stenosis
Being tested: Carotid artery revascularization procedure, Optical coherence tomography angiography
Keywords: Carotid Stenosis, OCTA
Medical subject headings: Carotid Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Carotid artery revascularization procedureProcedure or surgery
The patients with carotid artery stenosis will be examined before and after finishing the carotid artery revascularization procedure.
Optical coherence tomography angiographyDevice
Examination will be performed using optical coherence tomography angiography. This device allows quantitative analysis, since it provides numerical data about flow area and flow density maps.

Study groups in NCT04326842
Study group	Role	What they receive
Carotid artery stenosis		Patients with carotid artery stenosis. Procedure: Carotid artery revascularization procedure Receives: Procedure: Carotid artery revascularization procedure; Device: Optical coherence tomography angiography
Control		Patients without carotid artery stenosis Receives: Device: Optical coherence tomography angiography

What is being measured

The primary outcome is the main question the study is designed to answer.

Radical Peripapillary Capillaries Vessel Density
Radical peripapillary capillaries vessel density of Optical Coherence Tomography Angiography（OCTA）
Measured: Difference of vessel density in each group at baseline
Superficial Vascular Complexes Vessel Density
superficial vascular complexes vessel density of Optical Coherence Tomography Angiography
Measured: Difference of vessel density in each group at baseline
Deep Vascular Complexes Vessel Density
deep vascular complexes vessel density of Optical Coherence Tomography Angiography
Measured: Difference of vessel density in each group at baseline
Choriocapillaris Vessel Density
choriocapillaris vessel density of Optical Coherence Tomography Angiography
Measured: Difference of vessel density in each group at baseline

Secondary outcomes (6)

Change of Difference of Mean Transit Time(dMTT)
Change of dMTT is the dMTT value at 4 days after carotid artery procedure minus the value at baseline.
dMTT is that the value of the lesion side minus value of contralateral side. Mean transit time (MTT) corresponds to the average time, in seconds, that red blood cells spend within a determinate volume of capillary circulation.
Measured: baseline and 4 days after carotid artery procedure
Change of the Ratio of Cerebral Blood Flow(rCBF)
Change of rCBF is the rCBF value at 4 days after carotid artery procedure minus the value at baseline.
rCBF is that the CBF value of the lesion side divided by the value of contralateral side.
CBF refers to the flow of blood through a certain cross-sectional area of cerebrovascular per unit time.
Measured: baseline and 4 days after carotid artery procedure
Changes of Retinal Nerve Fiber Layer
changes of retinal nerve fiber layer of Optical Coherence Tomography Angiography
Measured: baseline and 4 days after carotid artery procedure
Changes of Deep Vascular Complexes Vessel Density
changes of deep vascular complexes vessel density of Optical Coherence Tomography Angiography
Measured: baseline and 4 days after carotid artery procedure
Changes of Radical Peripapillary Capillaries Vessel Density
changes of radical peripapillary capillaries vessel density of Optical Coherence Tomography Angiography
Measured: baseline and 4 days after carotid artery procedure
Changes of Superficial Vascular Complexes Vessel Density
changes of superficial vascular complexes vessel density of Optical Coherence Tomography Angiography
Measured: baseline and 4 days after carotid artery procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Apr 20202 Jul 2020

First posted30 Mar 2020
Study start2 Apr 2020
Primary completion20 Jun 2020
Study completion2 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Carotid StenosisStudies of the same condition, open and under way.
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: Retrospective
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04326842
Sponsor's protocol ID: HZHZS1
Status last verified: Apr 2020
First submitted: 24 Mar 2020
Last updated: 19 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Publications

Li X, Zhu S, Zhou S, Zhang Y, Ding Y, Zheng B, Wu P, Shi Y, Zhang H, Shi H. Optical Coherence Tomography Angiography as a Noninvasive Assessment of Cerebral Microcirculatory Disorders Caused by Carotid Artery Stenosis. Dis Markers. 2021 Jul 5;2021:2662031. doi: 10.1155/2021/2662031. eCollection 2021.
PubMed 34326905

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
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A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
Carotid Artery Stenosis
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders

All Carotid Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optical Coherence Tomography Angiography Evaluation of Ocular Changes in Patients With Carotid Artery Stenosis
ClinicalTrials.gov ID: NCT04326842
Acronym / sponsor ID: HZHZS1
Conditions: Carotid Stenosis
Keywords: Carotid Stenosis, OCTA
Study type: Observational
Recruitment status: Completed
Enrolment: 129 participants (actual)
Lead sponsor: First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
Study start: 2 Apr 2020 (actual)
Primary completion: 20 Jun 2020 (actual)
Study completion: 2 Jul 2020 (actual)
First posted: 30 Mar 2020 (actual)
Results: Posted 19 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study aims to evaluate ocular changes in patients with carotid artery stenosis by optical coherence tomography angiography before and after carotid artery revascularization procedure.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Carotid artery stenosis	–	Procedure: Carotid artery revascularization procedure, Device: Optical coherence tomography angiographyPatients with carotid artery stenosis. Procedure: Carotid artery revascularization procedure
Control	–	Device: Optical coherence tomography angiographyPatients without carotid artery stenosis

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Participants with carotid artery stenosis undergoing cerebral and eye examination and in routine clinical practice will be included

Key inclusion criteria (2 listed)

Clinical diagnosis of carotid artery stenosis
Age-gender-race-matched controls

Key exclusion criteria (8 listed)

age <18 years
intraocular pressure (IOP) >21 mmHg
VA >logMAR 1.0
spherical equivalent (SE) between >1.00 or < -6.00 D
other serious eye diseases which may affect OCTA results including diabetic retinopathy, hypertensive retinopathy, retinal vascular occlusion, age-related macular degeneration, and uveitis

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
Carotid artery revascularization procedureThe patients with carotid artery stenosis will be examined before and after finishing the carotid artery revascularization procedure.	Procedure or surgery	Carotid artery stenosis
Optical coherence tomography angiographyExamination will be performed using optical coherence tomography angiography. This device allows quantitative analysis, since it provides numerical data about flow area and flow density maps.	Device	Carotid artery stenosis, Control

Primary outcome

Radical Peripapillary Capillaries Vessel Density
Time frame: Difference of vessel density in each group at baseline
Radical peripapillary capillaries vessel density of Optical Coherence Tomography Angiography（OCTA）
Superficial Vascular Complexes Vessel Density
Time frame: Difference of vessel density in each group at baseline
superficial vascular complexes vessel density of Optical Coherence Tomography Angiography
Deep Vascular Complexes Vessel Density
Time frame: Difference of vessel density in each group at baseline
deep vascular complexes vessel density of Optical Coherence Tomography Angiography
Choriocapillaris Vessel Density
Time frame: Difference of vessel density in each group at baseline
choriocapillaris vessel density of Optical Coherence Tomography Angiography

6 secondary outcomes

Change of Difference of Mean Transit Time(dMTT)
Time frame: baseline and 4 days after carotid artery procedure
Change of the Ratio of Cerebral Blood Flow(rCBF)
Time frame: baseline and 4 days after carotid artery procedure
Changes of Retinal Nerve Fiber Layer
Time frame: baseline and 4 days after carotid artery procedure
Changes of Deep Vascular Complexes Vessel Density
Time frame: baseline and 4 days after carotid artery procedure
Changes of Radical Peripapillary Capillaries Vessel Density
Time frame: baseline and 4 days after carotid artery procedure
Changes of Superficial Vascular Complexes Vessel Density
Time frame: baseline and 4 days after carotid artery procedure

Results and safety

Results posted to the registry on 19 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Carotid Artery Stenosis	40	31
Control	89	31

Primary outcome: Radical Peripapillary Capillaries Vessel Density

Time frame: Difference of vessel density in each group at baseline. Median (Inter-Quartile Range). Unit: percentage of vessel

Measure	Carotid Artery Stenosis n = 31	Control n = 31
Value	55.95 (53.30 to 58.10)	57.24 (56.00 to 59.20)

Primary outcome: Superficial Vascular Complexes Vessel Density

Time frame: Difference of vessel density in each group at baseline. Median (Inter-Quartile Range). Unit: percentage of vessel

Measure	Carotid Artery Stenosis n = 31	Control n = 31
Value	48.65 (45.50 to 51.10)	52.22 (50.14 to 52.53)

Primary outcome: Deep Vascular Complexes Vessel Density

Time frame: Difference of vessel density in each group at baseline. Median (Inter-Quartile Range). Unit: percentage of vessel

Measure	Carotid Artery Stenosis n = 31	Control n = 31
Value	49.65 (46.50 to 53.70)	57.50 (53.80 to 59.85)

Primary outcome: Choriocapillaris Vessel Density

Time frame: Difference of vessel density in each group at baseline. Median (Inter-Quartile Range). Unit: percentage of vessel

Measure	Carotid Artery Stenosis n = 31	Control n = 31
Value	67.41 (62.90 to 69.92)	68.74 (65.91 to 71.11)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2weeks post-operation. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Carotid Artery Stenosis	1 of 31 (3.2%)	0 of 31 (0%)	0 of 31
Control	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34326905Li X, Zhu S, Zhou S, Zhang Y, Ding Y, Zheng B, Wu P, Shi Y, Zhang H, Shi H. Optical Coherence Tomography Angiography as a Noninvasive Assessment of Cerebral Microcirculatory Disorders Caused by Carotid Artery Stenosis. Dis Markers. 2021 Jul 5;2021:2662031. doi: 10.1155/2021/2662031. eCollection 2021.
Individual participant dataSharing planned: Undecided

Related trials for Carotid Stenosis

Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruitingObservational study
A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
Carotid Artery Stenosis
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
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RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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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. This study is not recruiting at the moment.

Hong Zhang principal investigator

First Affiliated Hospital of Harbin Medical University

Huaizhang Shi principal investigator

First Affiliated Hospital of Harbin Medical University

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 Carotid Stenosis, run by First Affiliated Hospital of Harbin Medical 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 19 Oct 2020. 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?

Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radical Peripapillary Capillaries Vessel Density (time frame: Difference of vessel density in each group at baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04326842, which also lists 1 linked publication.

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 19 Oct 2020.