AzTrials
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Intracranial AtherosclerosisRICASNCT06610578

ICAS Screen Based on RIC

An observational study of Intracranial Atherosclerosis, run by Xuanwu Hospital, Beijing at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Intracranial atherosclerosis stenosis (ICAS) is a leading cause of ischemic stroke worldwide and increase the global burden of stroke, especially in the Asian population. Compared with the other stroke subtypes, patients with ICAS had more severe stroke, stayed longer in the hospital and higher risk of recurrent… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Intracranial Atherosclerosis
What is being tested?
fundus imaging
How many people
2,100 participants
Where
1 siteChina
Study dates
5 Sep 2024to Sep 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Complete head and neck DSA, CTA, MRA or HR-MRI examination within 2 weeks;

Who may be able to join

  • The age is above 18 years old;
  • Complete head and neck DSA, CTA, MRA or HR-MRI examination within 2 weeks;
  • He/She can cooperate with follow-up fundus examination with free movement;
  • Signed informed consent.

Who cannot join

  • Poor quality of fundus images;
  • With intracranial mass lesions;
  • With severe heart, liver and kidney diseases;
  • With pregnancy and lactation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Xuanwu Hospital, Capital Medical University

    Beijing, None Selected, 100091

    Yuan Gao, 86+01083199439, gychina163@163.com

    Recruiting

Other trials in China

About this study

Official title: Intracranial Atherosclerosis Screen Based on Retinal Imaging Characteristic

Intracranial atherosclerosis stenosis (ICAS) is a leading cause of ischemic stroke worldwide and increase the global burden of stroke, especially in the Asian population. Compared with the other stroke subtypes, patients with ICAS had more severe stroke, stayed longer in the hospital and higher risk of recurrent ischemic events. Thus, early screening and effective intervention for intracranial atherosclerotic stenosis can improve the level of early warning and prevention of stroke, decrease the incidence and mortality of stroke, which is of vital significance. Although digital subtraction angiography (DSA), computed tomography angiography (CTA) and magnetic resonance angiography (MRA) have a high diagnostic value for ICAS, it is invasive and not available for mass population screening due to expertise, expensive cost, and poor economic performance. Potential screening tools such as transcranial doppler sonography (TCD) are promising but limited by temporal bone window quality and highly depends on operators' experience. Therefore, it is imperative to explore a novel, non-invasive, economic and complementary screening method for identifying the subjects with ICAS in mass populations such as primary health-care institutions and physical examination centers.

The retina develops from the diencephalon, shares the same embryological origin, anatomic features and physiological properties with brain, including blood supply via the internal carotid artery. A prospective cohort study has confirmed that retinal vascular signs (enhanced arteriolar light reflex) are related to intracranial large artery disease8. Rhee et al' study have also showed that retinal diameter variation is associated with ICAS9. Hence, these findings hint retinal vascular signs may be a biomarker for ICAS. Besides, the traditional vascular risk factors, such as older age, hypertension, diabetes, dyslipidemia, smoking and others, are also tightly associated with ICAS. However, few studies have reported the discrimination performance of retinal vascular signs itself or combining with the traditional vascular risk factors in identifying ICAS. Fundus photography has great advantages including non-invasive, easy to popularize, inexpensive and possess good economic benefits, particularly in the age of artificial intelligence. Artificial intelligence (AI), especially deep learning algorithm has widely applied to accurate varieties of retinal diseases detection and classification such as diabetic retinopathy and glaucoma. Besides, deep learning algorithm was also used to automatic segmentation of retinal arteries or veins, which provides a basis for the subsequent automatic calculation of retinal vascular parameters. In this study, we aim to study on screening for intracranial atherosclerosis and predicting stroke risk based on fundus imaging features.

Being tested
fundus imaging
Keywords
stroke, fundus imaging, intracranial atherosclerosis
Medical subject headings
Intracranial Arteriosclerosis, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fundus imagingDiagnostic test

    Fundus photography, OCT or OCTA

Study groups in NCT06610578
Study groupRoleWhat they receive
Participants with or without intracranial atherosclerosisNot described
Receives: Diagnostic Test: fundus imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The performance and applicability of the model

    The performance and applicability of the model(AUROC, sensitivity, specificity, accuracy)

    Measured: two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2024
  2. Study start5 Sep 2024
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

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
2,100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06610578
Sponsor's protocol ID
2024223001
Acronym
RICAS
Status last verified
Oct 2024
First submitted
18 Sep 2024
Last updated
31 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Intracranial Atherosclerosis, run by Xuanwu Hospital, Beijing 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 31 Oct 2024. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gao (86+01083199439, gychina163@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The performance and applicability of the model (time frame: two 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 31 Oct 2024.

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