Ischemic StrokeNCT05243849
Characterization of Retinal Microvascular and FAZ Changes in Ischemic Stroke and Its Different Types
An observational study of Ischemic Stroke, run by Peking University Third Hospital at 1 site in China.
Trial summary
The study aimed to access the microvascular changes in the superficial capillary plexus (SCP) and deep capillary plexus (DCP) in patients with ischemic stroke and its different types using optical coherence tomography angiography. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Optical Coherence Tomography Angiography
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to Jun 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who were diagnosed with ischemic stroke by MRI and healthy controls were scheduled for an OCTA examination.
Who may be able to join
- Patients who were diagnosed with ischemic stroke by MRI were scheduled for an OCTA examination. The diagnosis of ischemic stroke was obtained from previous diagnostic reports or electronic medical records, according to the diagnostic criteria from the Trial of Org 10172 in Acute Stroke Treatment (TOAST).
Who cannot join
- 1) Retinal diseases or diseases affecting vessel structure in fundus photography, including age-related maculopathy; diabetic retinopathy, central serous chorioretinopathy, retinal pigment epithelial detachment and glaucoma); poor cooperation in ophthalmic examinations; high refractive error (>+6.00 D or <-6.00 D Spherical Equivalent); low-quality OCTA images (signal strength index < 6/10). Inclusion criteria for healthy controls were no history of ischemic stroke or other neurological and ocular diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Hong Qi, PhD, 13901066889, doctorqihong@163.com
About this study
The study aimed to access the microvascular changes in the superficial capillary plexus (SCP) and deep capillary plexus (DCP) in patients with ischemic stroke and its different types using optical coherence tomography angiography.
Read the detailed description
Investigators used OCTA to quantitatively access the retinal microvasculature of SCP and DCP, aiming to detect the geometry changes of retinal microvasculature and FAZ in ischemic stroke patients and its different types.
- Conditions
- Ischemic Stroke
- Being tested
- Optical Coherence Tomography Angiography
- Keywords
- Ischemic Stroke, Optical Coherence Tomography Angiography, Retina
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography AngiographyDevice
Optical coherence tomography angiography (OCTA) is a novel non-invasive, non-dye and high-resolution imaging technique, allowing real-time quantitative evaluation of retinal vasculature and the structure of foveal avascular zone (FAZ).
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Stroke | The diagnosis of ischemic stroke was obtained from previous diagnostic reports or electronic medical records, according to the diagnostic criteria from the Trial of Org 10172 in Acute Stroke Treatment (TOAST). Receives: Device: Optical Coherence Tomography Angiography | |
| Control | Inclusion criteria for healthy controls were no history of ischemic stroke or other neurological and ocular diseases. Receives: Device: Optical Coherence Tomography Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular Area Density(VAD)
The total length in millimeters of perfused retinal microvasculature per unit area in square millimeters in the annular region of analyzed area
Measured: immediately after meeting the inclusion and exclusion criteria
Vascular Fractal Dimension(VFD)
A well-known parameter which indicates the degree of geometric complexity of vasculature
Measured: immediately after meeting the inclusion and exclusion criteria
Vascular Orientation Distribution(VOD)
The direction of each vascular pixel to indicate the trend of the blood flow
Measured: immediately after meeting the inclusion and exclusion criteria
FAZ Area(FA)
The total numbers of pixels in the FAZ region
Measured: immediately after meeting the inclusion and exclusion criteria
FAZ Axis Ratio(FAR)
The ratio between the major and minor axes of the fitted ellipse from the FAZ boundary. The axis ratio of a perfect circular FAZ is equal to 1
Measured: immediately after meeting the inclusion and exclusion criteria
FAZ Circularity(FC)
The ratio of the perimeter of the FAZ to the parameter of a circle with equal area, reflecting the degree of roundness of the FAZ
Measured: After meeting the inclusion and exclusion criteria
FAZ Roundness(FR)
Similar to FC, but is less sensitive to irregular borders along the parameter of FAZ
Measured: immediately after meeting the inclusion and exclusion criteria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 Jan 2022
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongyu Duan, MD, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243849
- Sponsor's protocol ID
- OCTA
- Status last verified
- Dec 2021
- First submitted
- 29 Dec 2021
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Retinal Microvascular and FAZ Changes in Ischemic Stroke and Its Different Types
- ClinicalTrials.gov ID
- NCT05243849
- Acronym / sponsor ID
- OCTA
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic Stroke, Optical Coherence Tomography Angiography, Retina
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 17 Feb 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 study aimed to access the microvascular changes in the superficial capillary plexus (SCP) and deep capillary plexus (DCP) in patients with ischemic stroke and its different types using optical coherence tomography angiography.
Detailed description
Investigators used OCTA to quantitatively access the retinal microvasculature of SCP and DCP, aiming to detect the geometry changes of retinal microvasculature and FAZ in ischemic stroke patients and its different types.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic Stroke | – | Device: Optical Coherence Tomography AngiographyThe diagnosis of ischemic stroke was obtained from previous diagnostic reports or electronic medical records, according to the diagnostic criteria from the Trial of Org 10172 in Acute Stroke Treatment (TOAST). |
| Control | – | Device: Optical Coherence Tomography AngiographyInclusion criteria for healthy controls were no history of ischemic stroke or other neurological and ocular diseases. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were diagnosed with ischemic stroke by MRI and healthy controls were scheduled for an OCTA examination.
Key inclusion criteria (1 listed)
- Patients who were diagnosed with ischemic stroke by MRI were scheduled for an OCTA examination. The diagnosis of ischemic stroke was obtained from previous diagnostic reports or electronic medical records, according to the diagnostic criteria from the Trial of Org 10172 in Acute Stroke Treatment (TOAST).
Key exclusion criteria (1 listed)
- 1) Retinal diseases or diseases affecting vessel structure in fundus photography, including age-related maculopathy; diabetic retinopathy, central serous chorioretinopathy, retinal pigment epithelial detachment and glaucoma); poor cooperation in ophthalmic examinations; high refractive error (>+6.00 D or <-6.00 D Spherical Equivalent); low-quality OCTA images (signal strength index < 6/10). Inclusion criteria for healthy controls were no history of ischemic stroke or other neurological and ocular diseases.
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 |
|---|---|---|
| Optical Coherence Tomography AngiographyOptical coherence tomography angiography (OCTA) is a novel non-invasive, non-dye and high-resolution imaging technique, allowing real-time quantitative evaluation of retinal vasculature and the structure of foveal avascular zone (FAZ). | Device | Control, Ischemic Stroke |
Primary outcome
Vascular Area Density(VAD)
Time frame: immediately after meeting the inclusion and exclusion criteria
The total length in millimeters of perfused retinal microvasculature per unit area in square millimeters in the annular region of analyzed area
Vascular Fractal Dimension(VFD)
Time frame: immediately after meeting the inclusion and exclusion criteria
A well-known parameter which indicates the degree of geometric complexity of vasculature
Vascular Orientation Distribution(VOD)
Time frame: immediately after meeting the inclusion and exclusion criteria
The direction of each vascular pixel to indicate the trend of the blood flow
FAZ Area(FA)
Time frame: immediately after meeting the inclusion and exclusion criteria
The total numbers of pixels in the FAZ region
FAZ Axis Ratio(FAR)
Time frame: immediately after meeting the inclusion and exclusion criteria
The ratio between the major and minor axes of the fitted ellipse from the FAZ boundary. The axis ratio of a perfect circular FAZ is equal to 1
FAZ Circularity(FC)
Time frame: After meeting the inclusion and exclusion criteria
The ratio of the perimeter of the FAZ to the parameter of a circle with equal area, reflecting the degree of roundness of the FAZ
FAZ Roundness(FR)
Time frame: immediately after meeting the inclusion and exclusion criteria
Similar to FC, but is less sensitive to irregular borders along the parameter of FAZ
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Hongyu Duan, MD study director
Peking University Third Hospital
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 Ischemic Stroke, run by Peking University Third Hospital 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 1 inclusion and 1 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 17 Feb 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 Hong Qi, PhD (13901066889, doctorqihong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular Area Density(VAD) (time frame: immediately after meeting the inclusion and exclusion criteria). The study lists 7 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 17 Feb 2022.