Early Diagnosis for Ocular Ischemia Syndrome Using Arterial Spin Labeling Magnetic Resonance Imaging Technique

Early Diagnosis for Ocular Ischemia Syndrome Using Arterial Spin Labeling Magnetic Resonance Imaging Technique: a Prospective Multicenter Cohort Study

1. To evaluate ocular blood perfusion status and the possibility of craniocerebral vascular lesions of patients with ocular ischemia syndrome (OIS) using arterial spin labeling (ASL) magnetic resonance imaging technique.
2. To evaluate the specificity, sensitivity and accuracy of arterial spin labeling (ASL) magnetic resonance imaging technique in OIS diagnosis, compared with the traditional routine examination method.

Study Overview

• Status: Unknown
• Conditions: Ocular Ischemia Syndrome
• Intervention / Treatment: Diagnostic test: Arterial spin labeling (ASL) magnetic resonance imaging; Diagnostic test: Fundus fluorescein angiography

• Study Type: Observational
• Enrollment (Anticipated): 190

Contacts and Locations

• Study Contact: Name: Yanling Wang, MD; Phone Number: +86-13701277114; Email: wangyanling999@vip.sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Friendship Hospital
      • Contact: Yanling Wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with ocular ischemia syndrome

Description

Inclusion Criteria:

• Ocular ischemia syndrome group: Patients diagnosed with ocular ischemia syndrome;
• Age-related macular degeneration group (Control group): Patients diagnosed with age-related macular degeneration;
• Age: 50-80 years;
• Sex: all;
• Patients signed written informed consent.

Exclusion Criteria:

• Fundus fluorescein angiography (FFA) clear images cannot be obtained due to refractive media problems(such as corneal leukoplakia, severe cataract, vitreous hemorrhage, etc.) ;
• Patients with contraindications for FFA;
• Patients was unable to perform magnetic resonance rmaging (MRI) test;
• Patients with history of bleeding and cerebral infarction;
• Patients with a history of surgery within 3 months;
• Patients who had participated in other clinical trials within 3 months;
• Patients who disagree and refuse to participate in the trial.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ocular ischemia syndrome; Patients with ocular ischemia syndrome	Diagnostic test: Arterial spin labeling (ASL) magnetic resonance imaging; Arterial spin labeling (ASL) magnetic resonance imaging test; Diagnostic test: Fundus fluorescein angiography; Fundus fluorescein angiography test
Control; Patients with age-related macular degeneration	Diagnostic test: Arterial spin labeling (ASL) magnetic resonance imaging; Arterial spin labeling (ASL) magnetic resonance imaging test; Diagnostic test: Fundus fluorescein angiography; Fundus fluorescein angiography test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Flow (BF)	Blood Flow (BF)：a parameter measured by arterial spin labeling perfusion MRI to qualify the perfusion in tissue-specific units (ml blood/gram tissue/time)	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Investigators: Principal Investigator: Yanling Wang, MD, Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: February 28, 2019
• First Submitted That Met QC Criteria: March 4, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 14, 2019
• Last Update Submitted That Met QC Criteria: March 12, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome; Ischemia
• Other Study ID Numbers: 2018-P2-185-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No