Ocular Ischemia SyndromeNCT03863171
Early Diagnosis for Ocular Ischemia Syndrome Using Arterial Spin Labeling Magnetic Resonance Imaging Technique
An observational study of Ocular Ischemia Syndrome, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Ocular Ischemia Syndrome
- What is being tested?
- Arterial spin labeling (ASL) magnetic resonance imaging and Fundus fluorescein angiography
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 1 Mar 2021
- 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 50 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with ocular ischemia syndrome
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality
Yanling Wang, MD
About this study
Official title: Early Diagnosis for Ocular Ischemia Syndrome Using Arterial Spin Labeling Magnetic Resonance Imaging Technique: a Prospective Multicenter Cohort Study
- 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.
- Conditions
- Ocular Ischemia Syndrome
- Being tested
- Arterial spin labeling (ASL) magnetic resonance imaging, Fundus fluorescein angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial spin labeling (ASL) magnetic resonance imagingDiagnostic test
Arterial spin labeling (ASL) magnetic resonance imaging test
Fundus fluorescein angiographyDiagnostic test
Fundus fluorescein angiography test
| Study group | Role | What they receive |
|---|---|---|
| Ocular ischemia syndrome | Patients with ocular ischemia syndrome Receives: Diagnostic Test: Arterial spin labeling (ASL) magnetic resonance imaging; Diagnostic Test: Fundus fluorescein angiography | |
| Control | Patients with age-related macular degeneration Receives: Diagnostic Test: Arterial spin labeling (ASL) magnetic resonance imaging; Diagnostic Test: Fundus fluorescein angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Mar 2019
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Ischemia SyndromeStudies of the same condition, open and under way.
- More trials run by Beijing Friendship 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yue Li, Beijing Friendship Hospital
- Investigators
- Yanling Wang, MD, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863171
- Sponsor's protocol ID
- 2018-P2-185-02
- Status last verified
- Mar 2019
- First submitted
- 28 Feb 2019
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis for Ocular Ischemia Syndrome Using Arterial Spin Labeling Magnetic Resonance Imaging Technique: a Prospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT03863171
- Acronym / sponsor ID
- 2018-P2-185-02
- Conditions
- Ocular Ischemia Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 5 Mar 2019 (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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ocular ischemia syndrome | – | Diagnostic Test: Arterial spin labeling (ASL) magnetic resonance imaging, Diagnostic Test: Fundus fluorescein angiographyPatients with ocular ischemia syndrome |
| Control | – | Diagnostic Test: Arterial spin labeling (ASL) magnetic resonance imaging, Diagnostic Test: Fundus fluorescein angiographyPatients with age-related macular degeneration |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with ocular ischemia syndrome
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
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 |
|---|---|---|
| Arterial spin labeling (ASL) magnetic resonance imagingArterial spin labeling (ASL) magnetic resonance imaging test | Diagnostic test | Control, Ocular ischemia syndrome |
| Fundus fluorescein angiographyFundus fluorescein angiography test | Diagnostic test | Control, Ocular ischemia syndrome |
Primary outcome
Blood Flow (BF)
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
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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.
Yanling Wang, MD principal investigator
Beijing Friendship 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 Ocular Ischemia Syndrome, run by Beijing Friendship 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 5 inclusion and 7 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 14 Mar 2019. 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 Yanling Wang, MD (+86-13701277114, wangyanling999@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Flow (BF) (time frame: through study completion, an average of 2 years). 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 14 Mar 2019.