Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT04881292
Status:
UNKNOWN
Last Update Posted:
2021-09-14
First Post:
2021-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RF Based QIMT & QAS Study on Chinese Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-13', 'studyFirstSubmitDate': '2021-05-01', 'studyFirstSubmitQcDate': '2021-05-05', 'lastUpdatePostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intima-media thickness', 'timeFrame': 'one-time measurement on the day of ultrasound examination', 'description': 'millimeter, one-time measurement throughout the study'}, {'measure': 'Carotid stiffness index', 'timeFrame': 'one-time measurement on the day of ultrasound examination', 'description': '=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'}, {'measure': 'Pulse wave velocity', 'timeFrame': 'one-time measurement on the day of ultrasound examination', 'description': 'm/sec,one-time measurement throughout the study'}, {'measure': 'Artery compliance coefficient', 'timeFrame': 'one-time measurement on the day of ultrasound examination', 'description': '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'}, {'measure': 'Age', 'timeFrame': 'one-time measurement on the day of ultrasound examination', 'description': 'years, one-time measurement throughout the study'}], 'secondaryOutcomes': [{'measure': 'blood pressure', 'timeFrame': 'one-time measurement on the day of ultrasound examination', 'description': 'mmHg, one-time measurement throughout the study'}, {'measure': 'fasting blood glucose', 'timeFrame': 'one-time measurement with 7 days before or after ultrasound examination', 'description': 'mmol/L, one-time measurement throughout the study'}, {'measure': 'Total cholesterol', 'timeFrame': 'one-time measurement with 7 days before or after ultrasound examination', 'description': 'mmol/L, one-time measurement throughout the study'}, {'measure': 'Triglycerides', 'timeFrame': 'one-time measurement with 7 days before or after ultrasound examination', 'description': 'mmol/L, one-time measurement throughout the study'}, {'measure': 'Height', 'timeFrame': 'one-time measurement on the day of ultrasound examination', 'description': 'm, one-time measurement throughout the study'}, {'measure': 'Weight', 'timeFrame': 'one-time measurement on the day of ultrasound examination', 'description': 'kg, one-time measurement throughout the study'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Adults', 'Carotid Intima-media Thickness', 'Vascular Stiffness', 'Chinese']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nTo 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.\n\nQuality Control including the pre-study training and data monitoring during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy Han Chinese adults', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-79\n* The blood pressure is normal: systolic blood pressure \\<140 mmHg, and diastolic blood pressure \\<90 mmHg\n* The physical examination and electrocardiogram are normal\n\nExclusion Criteria:\n\n* Subjects with carotid intima-media thickness ≥ 1.0 mm should be excluded;\n* 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.;\n* Subjects with past medical history and medication history of endocrine, rheumatism, chronic respiratory disease, liver and kidney disease should be excluded;\n* Obese subjects (BMI ≥ 28 kg/m2), professional athletes, pregnant and lactating women should be excluded;\n* Alcohol or drug addicts and smokers who have not quit smoking should be excluded.'}, 'identificationModule': {'nctId': 'NCT04881292', 'briefTitle': 'RF Based QIMT & QAS Study on Chinese Adults', 'organization': {'class': 'OTHER', 'fullName': 'Tang-Du Hospital'}, 'officialTitle': 'Reference Values of Carotid Intima-media Thickness and Arterial Stiffness in Chinese Adults Based on Ultrasound Radio Frequency Signal: A Nationwide, Multicenter Study', 'orgStudyIdInfo': {'id': '20210402V2.0'}}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xianyue Yang', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuqing Jiang', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of USTC', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Wu', 'role': 'CONTACT'}], 'facility': 'The Second Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bin Ma', 'role': 'CONTACT'}], 'facility': 'Air Force Medical Center', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jingfang Dong', 'role': 'CONTACT'}], 'facility': 'Beijing University of Chinese Medicine Third Affiliated Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Mao', 'role': 'CONTACT'}], 'facility': 'Second Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Nanning', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiao Que', 'role': 'CONTACT'}], 'facility': 'First Affiliated Hospital of Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'city': 'Guiyang', 'state': 'Guizhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bei Zhang', 'role': 'CONTACT'}], 'facility': 'The Afffiliated Hospital of Guizhou Medical University', 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Juhong Pan', 'role': 'CONTACT'}], 'facility': 'Renmin Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Wu', 'role': 'CONTACT'}], 'facility': 'Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenhui Zhu', 'role': 'CONTACT'}], 'facility': 'Third Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Baotou', 'state': 'Inner Mongolia', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shiji Wang', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology', 'geoPoint': {'lat': 40.6516, 'lon': 109.84389}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianxiang Wang', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital with Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Na Su', 'role': 'CONTACT'}], 'facility': 'The First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '110004', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaona Yu', 'role': 'CONTACT'}], 'facility': 'Shengjing Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huangliang Liu', 'role': 'CONTACT'}], 'facility': 'First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Qingdao', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongmei Sun', 'role': 'CONTACT'}], 'facility': 'The Affiliated Hospital of Qingdao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ri Ji', 'role': 'CONTACT'}], 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '710038', 'city': "Xi'an", 'state': 'Shannxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Changyang Xing', 'role': 'CONTACT'}], 'facility': 'Tangdu Hospital, Air Force Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '710068', 'city': "Xi'an", 'state': 'Shannxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Aihua Wei', 'role': 'CONTACT'}], 'facility': "Shannxi Provincial People's Hospital", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': "Xi'an", 'state': 'Shannxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hao Wang', 'role': 'CONTACT'}], 'facility': 'GEM Flower Xian Changqing Staff Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': "Xi'an", 'state': 'Shannxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fan Li', 'role': 'CONTACT'}], 'facility': 'Hospital of Northwestern Polytechnical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': "Xi'an", 'state': 'Shannxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ting Liu', 'role': 'CONTACT'}], 'facility': "Second Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': "Xi'an", 'state': 'Shannxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hengli Yang', 'role': 'CONTACT'}], 'facility': "The Second Affiliated Hospital of Xi'an Medical University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': "Xi'an", 'state': 'Shannxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xue Dong', 'role': 'CONTACT'}], 'facility': "Xi'an Central Hospital", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': "Xi'an", 'state': 'Shannxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaojun Zhan', 'role': 'CONTACT'}], 'facility': "Xi'an No.1 Hospital", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qianjun Ye', 'role': 'CONTACT'}], 'facility': 'First Hospital of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Xianyang', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bei Jia', 'role': 'CONTACT'}], 'facility': "Xianyang Hospital of Yan'an University"}, {'city': 'Ürümqi', 'state': 'Xijiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Zhuang', 'role': 'CONTACT'}], 'facility': 'General Hospital of Xinjiang Production and Construction Corps', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'city': 'Karamay', 'state': 'Xinjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Erke Zhang', 'role': 'CONTACT'}], 'facility': 'Karamay Central Hospital of Xinjiang', 'geoPoint': {'lat': 45.58473, 'lon': 84.88724}}, {'city': 'Ürümqi', 'state': 'Xinjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ting Ma', 'role': 'CONTACT'}], 'facility': 'First Affiliated Hospital of Xinjiang Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'city': 'Ürümqi', 'state': 'Xinjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhanlei Chen', 'role': 'CONTACT'}], 'facility': 'The Fourth Affiliated Hospital of Xinjiang Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'city': 'Kunming', 'state': 'Yunnan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuan Su', 'role': 'CONTACT'}], 'facility': 'Yan An Hospital Affiliated to Kunming Medical University', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'zip': '310012', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiujing Xie', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Changyang Xing, PhD; MD', 'role': 'CONTACT', 'email': 'xingcy712@163.com', 'phone': '13571864787'}], 'overallOfficials': [{'name': 'Lijun Yuan, PhD; MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tangdu Hospital-Air Force Medical University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'starting 6 months after publication', 'ipdSharing': 'YES', 'description': 'All IPD that underlie results in a publication', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Esaote (Shenzhen) Medical Equipment Co. Ltd', 'class': 'UNKNOWN'}, {'name': 'Zhejiang University', 'class': 'OTHER'}, {'name': "Shannxi Provincial People's Hospital", 'class': 'UNKNOWN'}, {'name': 'Shengjing Hospital', 'class': 'OTHER'}, {'name': 'First Hospital of China Medical University', 'class': 'OTHER'}, {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': 'Renmin Hospital of Wuhan University', 'class': 'OTHER'}, {'name': 'Beijing University of Chinese Medicine Third Affiliated Hospital', 'class': 'UNKNOWN'}, {'name': 'The First Affiliated Hospital of Shanxi Medical University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology', 'class': 'UNKNOWN'}, {'name': 'The First Hospital of Jilin University', 'class': 'OTHER'}, {'name': 'The Afffiliated Hospital of Guizhou Medical University', 'class': 'UNKNOWN'}, {'name': 'Yan An Hospital Affiliated to Kunming Medical University', 'class': 'UNKNOWN'}, {'name': 'Second Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, {'name': 'The Third Xiangya Hospital of Central South University', 'class': 'OTHER'}, {'name': 'Ruijin Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Anhui Medical University', 'class': 'OTHER'}, {'name': 'The Second Hospital of Anhui Medical University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of USTC', 'class': 'UNKNOWN'}, {'name': 'The Affiliated Hospital of Qingdao University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Xinjiang Medical University', 'class': 'OTHER'}, {'name': 'Hospital of Northwestern Polytechnical University', 'class': 'UNKNOWN'}, {'name': 'GEM Flower Xian Changqing Staff Hospital', 'class': 'UNKNOWN'}, {'name': "Xi'an Central Hospital", 'class': 'OTHER'}, {'name': "Second Affiliated Hospital of Xi'an Jiaotong University", 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Guangxi Medical University', 'class': 'OTHER'}, {'name': 'Karamay Central Hospital of Xinjiang', 'class': 'UNKNOWN'}, {'name': 'Fourth Affiliated Hospital of Xinjiang Medical University', 'class': 'OTHER'}, {'name': "Xi'an No.1 Hospital", 'class': 'UNKNOWN'}, {'name': "Xianyang Hospital of Yan'an University", 'class': 'UNKNOWN'}, {'name': 'General Hospital of Xinjiang Production and Construction Corps', 'class': 'UNKNOWN'}, {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the department of ultrasound diagnostics', 'investigatorFullName': 'Lijun Yuan, MD, PhD', 'investigatorAffiliation': 'Tang-Du Hospital'}}}}