Characterization of Retinal Microvascular and FAZ Changes in Ischemic Stroke and Its Different Types

NCT05243849 | Unknown DMC

• 1 other identifier: OCTA
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke

Keywords

Ischemic Stroke; Optical Coherence Tomography Angiography; Retina

Outcome Measures

Primary Outcomes (7)

• 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

  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

  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

  immediately after meeting the inclusion and exclusion criteria

• FAZ Area(FA)

  The total numbers of pixels in the FAZ region

  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

  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

  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

  immediately after meeting the inclusion and exclusion criteria

Study Arms (2)

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).

Device: Optical Coherence Tomography Angiography

Control

Inclusion criteria for healthy controls were no history of ischemic stroke or other neurological and ocular diseases.

Device: Optical Coherence Tomography Angiography

Interventions

Optical Coherence Tomography Angiography DEVICE

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).

Control; Ischemic Stroke

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were diagnosed with ischemic stroke by MRI and healthy controls were scheduled for an OCTA examination.

You may qualify if:

• 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).

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hongyu Duan, MD

  Peking University Third Hospital

  STUDY DIRECTOR

Central Study Contacts

Hong Qi, PhD

CONTACT

13901066889; doctorqihong@163.com

Hongyu Duan, MD

CONTACT

18813120970; hyduan167@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: February 17, 2022
• Study Start: January 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 17, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)