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

Sponsor

Beijing Friendship Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03863171

Collaborator

(none)

190

Enrollment

Location

Anticipated Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.
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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Ischemia Syndrome	Diagnostic Test: Arterial spin labeling (ASL) magnetic resonance imaging Diagnostic Test: Fundus fluorescein angiography

Study Design

Study Type:

Observational

Anticipated Enrollment :

190 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2019

Anticipated Primary Completion Date :

Mar 1, 2020

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Blood Flow (BF) [through study completion, an average of 2 years]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Friendship Hospital	Beijing	Beijing	China

Sponsors and Collaborators

Beijing Friendship Hospital

Investigators

Principal Investigator: Yanling Wang, MD, Beijing Friendship Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yue Li, Clinical Professor, Beijing Friendship Hospital

ClinicalTrials.gov Identifier:

NCT03863171

Other Study ID Numbers:

2018-P2-185-02

First Posted:

Mar 5, 2019

Last Update Posted:

Mar 14, 2019

Last Verified:

Mar 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Syndrome

Ischemia

Study Results

No Results Posted as of Mar 14, 2019