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Intelligent Analysis and Clinical Validation of Cerebral Small Vessel Disease on Magnetic Resonance Imaging:A Multi-center Study

Intelligent Analysis and Clinical Validation of Cerebral Small Vessel Disease on Magnetic Resonance Imaging:A Multi-center Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06667635
Enrollment
1000
Registered
2024-10-31
Start date
2024-11-01
Completion date
2030-09-01
Last updated
2024-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Small Vessel Disease

Keywords

Cerebral small vessel disease, Artificial intelligence, Deep learning, Magnetic resonance imaging

Brief summary

Cerebral small vessel disease (CSVD) accounts for 20% of ischemic strokes and is the most common cause of vascular cognitive impairment. Early identification of CSVD is critical for early intervention and improve clinical outcomes. Magnetic resonance imaging (MRI) may represent as a sensitive and robust tool to detect early changes in brain subtle structures and functions. The study is to investigate the comprehensive evaluation by using AI in early diagnosis and management of CSVD.

Detailed description

Cerebral small vessel disease (CSVD) is an important cause of stroke, cognitive impairment, and other diseases, and its early quantitative evaluation can significantly improve patient prognosis. Magnetic resonance imaging (MRI) is an important method to evaluate the occurrence, development, and severity of CSVD. However, the diagnostic process lacks quantitative evaluation criteria and is limited by experience, which may easily lead to missed diagnoses and misdiagnoses. Based on the current technical challenges, subject development and upgrade of knowledge, to avoid the occurrence of adverse medical accidents, simplify the diagnostic process, artificial intelligence(AI) has become the alternative method of choice, by constructing training deep learning model,which can assist doctors in clinical decision-making to improve diagnosis effectiveness of CSCD detection and diagnosis.

Interventions

DIAGNOSTIC_TESTArtificial intelligence

Artificial intelligence (AI) tools developed through the training of large amounts of image data can assist with the analysis and interpretation of neuroimaging data of cerebral small vascular disease(CSVD).

Sponsors

Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* ① Men and women age 40 years or older; * At least one vascular risk factor has been identified, including hypertension, diabetes, hyperlipidemia, coronary heart disease, and chronic kidney disease; * The patient performed two brain MRI Examinations simultaneously at a time interval of more than 6 months (≥6).

Exclusion criteria

* ① The patient had no vascular risk factors; * No clinical follow-up images; * There are significant motion artifacts in the image, which cannot meet the

Design outcomes

Primary

MeasureTime frameDescription
The performance of AI in lesion detection and diagnosis2 yearThe performance of AI in lesion detection and diagnosis, including imaging quality, accuracy, sensitivity and specificity in lesion detection and imaging diagnosis.

Countries

China

Contacts

Primary ContactChaobang Xie
chaobangxie@163.com18798120676

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026