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NCT Number: NCT06667635

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

artificial intelligence

Diagnostic Test

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).

Primary outcomes

  1. The performance of AI in lesion detection and diagnosis

    Time frame: 2 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Chaobang Xie

CONTACT

[email protected]

18798120676

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Oct 31, 2024
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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