RF Based QIMT & QAS Study on Chinese Adults

• Sponsor: Tang-Du Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04881292
• Collaborator: Esaote (Shenzhen) Medical Equipment Co. Ltd (Other), The First Affiliated Hospital, Zhejiang University School of Medicine (Other), Shannxi Provincial People's Hospital (Other), Shengjing Hospital (Other), First Hospital of China Medical University (Other), Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology (Other), Renmin Hospital of Wuhan University (Other), Beijing University of Chinese Medicine Third Affiliated Hospital (Other), The First Affiliated Hospital of Shanxi Medical University (Other), The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology (Other), The First Hospital of Jilin University (Other), The Afffiliated Hospital of Guizhou Medical University (Other), Yan An Hospital Affiliated to Kunming Medical University (Other), Second Affiliated Hospital of Guangzhou Medical University (Other), Third Xiangya Hospital of Central South University (Other), Ruijin Hospital (Other), The First Affiliated Hospital with Nanjing Medical University (Other), The First Affiliated Hospital of Anhui Medical University (Other), The Second Hospital of Anhui Medical University (Other), The First Affiliated Hospital of USTC (Other), The Affiliated Hospital of Qingdao University (Other), First Affiliated Hospital of Xinjiang Medical University (Other), Hospital of Northwestern Polytechnical University (Other), GEM Flower Xian Changqing Staff Hospital (Other), Xi'an Central Hospital (Other), The Second Affiliated Hospital of Xi'an Medical University (Other), Second Affiliated Hospital of Xi'an Jiaotong University (Other), First Affiliated Hospital of Guangxi Medical University (Other), Karamay Central Hospital of Xinjiang (Other), The Fourth Affiliated Hospital of Xinjiang Medical University (Other), Xi'an No.1 Hospital (Other), Xianyang Hospital of Yan'an University (Other), General Hospital of Xinjiang Production and Construction Corps (Other), Air Force Medical Center (Other)
• Enrollment: 3,500
• Locations: 34
• Anticipated Duration (Months): 12
• Patients Per Site: 102.9
• Patients Per Site Per Month: 8.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy; Adults; Carotid Intima-media Thickness; Vascular Stiffness; Chinese

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 3500 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Reference Values of Carotid Intima-media Thickness and Arterial Stiffness in Chinese Adults Based on Ultrasound Radio Frequency Signal: A Nationwide, Multicenter Study
• Actual Study Start Date: May 1, 2021
• Anticipated Primary Completion Date: May 1, 2022
• Anticipated Study Completion Date: May 1, 2022

Outcome Measures

Primary Outcome Measures

1. Intima-media thickness [one-time measurement on the day of ultrasound examination]

   millimeter, one-time measurement throughout the study

2. Carotid stiffness index [one-time measurement on the day of ultrasound examination]

   =D▪ln(Ps/Pd)/ΔD, D: diastolic carotid diameter; Ps, systolic pressure; Pd, diastolic pressure; ΔD: Change of diameter in systolic. one-time measurement throughout the study

3. Pulse wave velocity [one-time measurement on the day of ultrasound examination]

   m/sec,one-time measurement throughout the study

4. Artery compliance coefficient [one-time measurement on the day of ultrasound examination]

   mm2kPa-1; =π▪(2▪D▪ΔD+ΔD2)/4▪ΔP; D: Diastolic diameter; ΔD: Change of diameter in systolic; ΔP, pulse pressure. one-time measurement throughout the study

5. Age [one-time measurement on the day of ultrasound examination]

   years, one-time measurement throughout the study

Secondary Outcome Measures

1. blood pressure [one-time measurement on the day of ultrasound examination]

   mmHg, one-time measurement throughout the study

2. fasting blood glucose [one-time measurement with 7 days before or after ultrasound examination]

   mmol/L, one-time measurement throughout the study

3. Total cholesterol [one-time measurement with 7 days before or after ultrasound examination]

   mmol/L, one-time measurement throughout the study

4. Triglycerides [one-time measurement with 7 days before or after ultrasound examination]

   mmol/L, one-time measurement throughout the study

5. Height [one-time measurement on the day of ultrasound examination]

   m, one-time measurement throughout the study

6. Weight [one-time measurement on the day of ultrasound examination]

   kg, one-time measurement throughout the study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Aged 18-79

• The blood pressure is normal: systolic blood pressure <140 mmHg, and diastolic blood pressure <90 mmHg

• The physical examination and electrocardiogram are normal

Exclusion Criteria:

• Subjects with carotid intima-media thickness ≥ 1.0 mm should be excluded;

• Subjects with previous cardiovascular disease history and medication history should be excluded. The main diseases include coronary heart disease, congenital heart disease, heart failure, hypertension, stroke, hyperlipidemia, diabetes, aortic arteritis, etc.;

• Subjects with past medical history and medication history of endocrine, rheumatism, chronic respiratory disease, liver and kidney disease should be excluded;

• Obese subjects (BMI ≥ 28 kg/m2), professional athletes, pregnant and lactating women should be excluded;

• Alcohol or drug addicts and smokers who have not quit smoking should be excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui	China
2	The First Affiliated Hospital of USTC	Hefei	Anhui	China
3	The Second Hospital of Anhui Medical University	Hefei	Anhui	China
4	Air Force Medical Center	Beijing	Beijing	China
5	Beijing University of Chinese Medicine Third Affiliated Hospital	Beijing	Beijing	China
6	Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China
7	First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi	China
8	The Afffiliated Hospital of Guizhou Medical University	Guiyang	Guizhou	China
9	Renmin Hospital of Wuhan University	Wuhan	Hubei	China
10	Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei	China
11	Third Xiangya Hospital of Central South University	Changsha	Hunan	China
12	The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology	Baotou	Inner Mongolia	China
13	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu	China
14	The First Hospital of Jilin University	Changchun	Jilin	China
15	Shengjing Hospital of China Medical University	Shenyang	Liaoning	China	110004
16	First Hospital of China Medical University	Shenyang	Liaoning	China
17	The Affiliated Hospital of Qingdao University	Qingdao	Shandong	China
18	Ruijin Hospital	Shanghai	Shanghai	China
19	Tangdu Hospital, Air Force Medical University	Xi'an	Shannxi	China	710038
20	Shannxi Provincial People's Hospital	Xi'an	Shannxi	China	710068
21	GEM Flower Xian Changqing Staff Hospital	Xi'an	Shannxi	China
22	Hospital of Northwestern Polytechnical University	Xi'an	Shannxi	China
23	Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shannxi	China
24	The Second Affiliated Hospital of Xi'an Medical University	Xi'an	Shannxi	China
25	Xi'an Central Hospital	Xi'an	Shannxi	China
26	Xi'an No.1 Hospital	Xi'an	Shannxi	China
27	First Hospital of Shanxi Medical University	Taiyuan	Shanxi	China
28	Xianyang Hospital of Yan'an University	Xianyang	Shanxi	China
29	General Hospital of Xinjiang Production and Construction Corps	Urumqi	Xijiang	China
30	Karamay Central Hospital of Xinjiang	Karamay	Xinjiang	China
31	First Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang	China
32	The Fourth Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang	China
33	Yan An Hospital Affiliated to Kunming Medical University	Kunming	Yunnan	China
34	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310012

Sponsors and Collaborators

• Tang-Du Hospital
• Esaote (Shenzhen) Medical Equipment Co. Ltd
• The First Affiliated Hospital, Zhejiang University School of Medicine
• Shannxi Provincial People's Hospital
• Shengjing Hospital
• First Hospital of China Medical University
• Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
• Renmin Hospital of Wuhan University
• Beijing University of Chinese Medicine Third Affiliated Hospital
• The First Affiliated Hospital of Shanxi Medical University
• The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
• The First Hospital of Jilin University
• The Afffiliated Hospital of Guizhou Medical University
• Yan An Hospital Affiliated to Kunming Medical University
• Second Affiliated Hospital of Guangzhou Medical University
• Third Xiangya Hospital of Central South University
• Ruijin Hospital
• The First Affiliated Hospital with Nanjing Medical University
• The First Affiliated Hospital of Anhui Medical University
• The Second Hospital of Anhui Medical University
• The First Affiliated Hospital of USTC
• The Affiliated Hospital of Qingdao University
• First Affiliated Hospital of Xinjiang Medical University
• Hospital of Northwestern Polytechnical University
• GEM Flower Xian Changqing Staff Hospital
• Xi'an Central Hospital
• The Second Affiliated Hospital of Xi'an Medical University
• Second Affiliated Hospital of Xi'an Jiaotong University
• First Affiliated Hospital of Guangxi Medical University
• Karamay Central Hospital of Xinjiang
• The Fourth Affiliated Hospital of Xinjiang Medical University
• Xi'an No.1 Hospital
• Xianyang Hospital of Yan'an University
• General Hospital of Xinjiang Production and Construction Corps
• Air Force Medical Center

Investigators

• Principal Investigator: Lijun Yuan, PhD; MD, Tangdu Hospital, Air Force Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lijun Yuan, MD, PhD, Director of the department of ultrasound diagnostics, Tang-Du Hospital
• ClinicalTrials.gov Identifier: NCT04881292
• Other Study ID Numbers: 20210402V2.0
• First Posted: May 11, 2021
• Last Update Posted: Sep 14, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 14, 2021