NCT04881292

RF Based QIMT & QAS Study on Chinese Adults

Reference Values of Carotid Intima-media Thickness and Arterial Stiffness in Chinese Adults Based on Ultrasound Radio Frequency Signal: A Nationwide, Multicenter Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 3,500 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

This study intends to establish the normal reference values of carotid artery intima-media thickness and vascular elasticity of Chinese adults based on ultrasound radio frequency technology through a multi-center large-sample study, which provides important information for the risk prediction and prognosis evaluation of Chinese adults' cardiovascular disease.

Detailed description

After being informed about the study, all participants giving written informed consent will undergo a one-time examination of vascular ultrasound, including general characteristics and the target ultrasound parameters. To detect the smallest difference between adjacent age groups within the age range 18-79 (6 groups, α = 0.05, β = 0.20, Statistical Power = 0.80). Given the influence of multiple centers, the minimum sample size is 1800, the optimal sample size is 3500. The male to female ratio is 1:1. Quality Control including the pre-study training and data monitoring during the study.

Conditions

• Healthy
• Adults
• Carotid Intima-media Thickness
• Vascular Stiffness
• Chinese

Timeline

• Start date: 2021-05-01
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2021-05-11
• Last updated: 2021-09-14

Locations

34 sites across 1 country: China