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NCT Number: NCT04326842

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

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.

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Key information

Conditions

Carotid Stenosis Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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).

Treatment and study plan

Carotid artery revascularization procedure

Procedure

The patients with carotid artery stenosis will be examined before and after finishing the carotid artery revascularization procedure.

Optical coherence tomography angiography

Device

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.

Primary outcomes

  1. 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）

  2. 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

  3. 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

  4. Choriocapillaris Vessel Density

    Time frame: Difference of vessel density in each group at baseline

    choriocapillaris vessel density of Optical Coherence Tomography Angiography

Secondary outcomes

  1. Change of Difference of Mean Transit Time(dMTT)

    Time frame: baseline and 4 days after carotid artery procedure

    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.

  2. Change of the Ratio of Cerebral Blood Flow(rCBF)

    Time frame: baseline and 4 days after carotid artery procedure

    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.

  3. Changes of Retinal Nerve Fiber Layer

    Time frame: baseline and 4 days after carotid artery procedure

    changes of retinal nerve fiber layer of Optical Coherence Tomography Angiography

  4. Changes of Deep Vascular Complexes Vessel Density

    Time frame: baseline and 4 days after carotid artery procedure

    changes of deep vascular complexes vessel density of Optical Coherence Tomography Angiography

  5. Changes of Radical Peripapillary Capillaries Vessel Density

    Time frame: baseline and 4 days after carotid artery procedure

    changes of radical peripapillary capillaries vessel density of Optical Coherence Tomography Angiography

  6. Changes of Superficial Vascular Complexes Vessel Density

    Time frame: baseline and 4 days after carotid artery procedure

    changes of superficial vascular complexes vessel density of Optical Coherence Tomography Angiography

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Harbin Medical University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 30, 2020
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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