Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-28 @ 9:32 AM
Study NCT ID:
NCT02496858
Status:
UNKNOWN
Last Update Posted:
2019-02-21
First Post:
2015-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Genetic Characteristics of Coronary Artery Disease in Chinese Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '2 samples of EDTA blood (2ml glass) and 1 sample of serum (2ml glass) will be retained in a biobank.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-20', 'studyFirstSubmitDate': '2015-07-07', 'studyFirstSubmitQcDate': '2015-07-09', 'lastUpdatePostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of cardiac death', 'timeFrame': '36 months', 'description': 'Any death from cardiac conditions'}, {'measure': 'Number of patients developing myocardial infarction', 'timeFrame': '36 months', 'description': 'Any case of acute myocardial infarction which meet the Criteria according to current guidelines.'}, {'measure': 'Number of patients developing stroke', 'timeFrame': '36 months', 'description': 'Any events of ishcemic stroke, TIA or hemorrhagic stroke'}, {'measure': 'Number of participants undergoing unscheduled repeat revascularization of target or non-target vessel', 'timeFrame': '36 months', 'description': 'Any unshceduled percutaneous coronary intervention or coronary artery bypass grafting after primary revascularization'}], 'secondaryOutcomes': [{'measure': 'Number of stent thrombosis, bleeding、non-cardiac death and all-cause death.', 'timeFrame': '36 months', 'description': 'Composite of stent thrombosis, bleeding、non-cardiac death and all-cause death.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Young Patient', 'Genetic Characteristics'], 'conditions': ['Coronary Artery Disease', 'Percutaneous Coronary Intervention']}, 'referencesModule': {'references': [{'pmid': '39673281', 'type': 'DERIVED', 'citation': 'Wu R, Su Y, Liao J, Shen J, Ma Y, Gao W, Dong Z, Dai Y, Yao K, Ge J. Exome Sequencing Identified Susceptible Genes for High Residual Risks in Early-Onset Coronary Atherosclerotic Disease. Clin Cardiol. 2024 Dec;47(12):e70066. doi: 10.1002/clc.70066.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to identify genetic loci,or gene variations contributing to the development of coronary artery disease (CAD) in Chinese young adults. Investigators will compare coronary angiogram results to genetic findings within young CAD patients.', 'detailedDescription': 'During last 10 years, the rise in coronary artery disease (CAD) prevalence in Chinese young adults is observed and percutaneous coronary intervention (PCI) is generally considered to be low operative risk in these young patients. Genome-wide association studies have identified a considerable number of common genetic variants related to CAD. However, the extent to which these genetic variants are related to the future cardiovascular events, the prevalence, extent, severity, and prognosis of young patients with CAD is not clear.\n\nThe aim of this study is to investigate the genetic loci, or gene variations contributing to the development and prognosis of CAD in Chinese young adult. Investigators will compare the angiogram results to genetic findings first in patients with different stages of CAD. Then, investigators will collect patients from hospital discharge registry, and compare long-term outcome as well as on operative details in different gene groups.\n\nThe results of the study provide a possibility to develop a gene test to recognize patients at risk at its early stage, and needing for preventive medicine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged ≤45 years diagnosed with CAD by coronary angiography will be collected from multiple institutions.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. premature CAD, includes patients who aged ≥ 18 and ≤ 45 years , and with at least one main coronary artery stenosis ≥ 50% confirmed by coronary angiography, involving left main coronary artery, left anterior descending branch, left circumflex branch or right coronary artery, and manifested as occult CAD, stable CAD, unstable angina pectoris, non-ST segment elevated myocardial infarction and ST segment elevated myocardial infarction;\n2. mature CAD, refers to patients who aged ≥ 65 years and meat the same CAD diagnostic criteria as above;\n3. age matched individuals who had coronary arteries without obvious stenosis.\n\nExclusion criteria:\n\n1. severely sick with limited life-expectancy \\< 1 year;\n2. patients with malignancies;\n3. pregnant or planning for pregnancy.'}, 'identificationModule': {'nctId': 'NCT02496858', 'acronym': 'GRAND', 'briefTitle': 'Clinical and Genetic Characteristics of Coronary Artery Disease in Chinese Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Clinical and Genetic Characteristics of Coronary Artery Disease in Chinese Young Adults', 'orgStudyIdInfo': {'id': 'ZS-CV-2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early-onset CAD', 'description': 'The anticipated 2000 young CAD patients who aged ≤45years undergoing coronary angiography will be recruited in the prospective cohort. Medical history and risk-factor information were obtained by interviewing patients and by abstracting information from medical records.'}, {'label': 'Late-onset CAD', 'description': 'The anticipated 2000 old CAD patients aged≥65years undergoing coronary angiography will be recruited in the prospective cohort. Medical history and risk-factor information were obtained by interviewing patients and by abstracting information from medical records.'}, {'label': 'Age-matched controls', 'description': 'The anticipated 2000 control subjects without obvious coronary stenosis aged≤45years or ≥65years will be recruited in the prospective cohort. Medical history and risk-factor information were obtained by interviewing patients and by abstracting information from medical records.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jingang Zheng', 'role': 'CONTACT'}], 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Xiamen', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Wang', 'role': 'CONTACT'}], 'facility': 'Xiamen Cardiovascular Hospital', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'city': 'Lanzhou', 'state': 'Gansu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zheng Zhang', 'role': 'CONTACT'}], 'facility': 'The First Hospital of Lanzhou University', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yingling Zhou', 'role': 'CONTACT'}], 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jingfeng Wang', 'role': 'CONTACT'}], 'facility': 'Sun yat-sen Memorial Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Zhuhai', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yingling Zhou', 'role': 'CONTACT'}], 'facility': "Zhuhai Hospital of Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 22.27694, 'lon': 113.56778}}, {'city': 'Nanning', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guixin He', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'city': 'Zunyi', 'state': 'Guizhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bei Shi', 'role': 'CONTACT'}], 'facility': 'Affiliated Hospital of Zunyi Medical College', 'geoPoint': {'lat': 27.68667, 'lon': 106.90722}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongjun Li', 'role': 'CONTACT'}], 'facility': 'The second Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xi Su', 'role': 'CONTACT'}], 'facility': 'Wuhan Asia Heart Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuxi', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoyan Wang', 'role': 'CONTACT'}], 'facility': "Wuxi Third People's Hospital", 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'city': 'Xuzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yijie Huang', 'role': 'CONTACT'}], 'facility': "Xuzhou Fourth People's Hospital", 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zeqi Zheng', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bin Liu', 'role': 'CONTACT'}], 'facility': 'The second Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Yinchuan', 'state': 'Ningxia', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shaobin Jia', 'role': 'CONTACT'}], 'facility': 'General Hospital of Ningxia Medical University', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}, {'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanni Wang', 'role': 'CONTACT'}], 'facility': "The First Affiliated Hospital of Xi 'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kang Yao', 'role': 'CONTACT', 'phone': '86-13818988550'}, {'name': 'Yuxiang Dai', 'role': 'CONTACT'}, {'name': 'Junbo Ge, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiangdong Xu', 'role': 'CONTACT'}], 'facility': 'Central Hospital of Jiading District', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Hu', 'role': 'CONTACT'}], 'facility': 'Central Hospital of Minhang District', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Pengxiang Zheng', 'role': 'CONTACT'}], 'facility': 'Central Hospital of Yangpu District', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xianxian Zhao', 'role': 'CONTACT'}], 'facility': 'Changhai Hospital of Second Military Medical University of Chinese PLA', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chun Liang', 'role': 'CONTACT'}], 'facility': 'Shanghai Changzheng Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ben He', 'role': 'CONTACT'}], 'facility': 'Shanghai chest hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shaowen Liu', 'role': 'CONTACT'}], 'facility': "Shanghai First People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junfeng Zhang', 'role': 'CONTACT'}], 'facility': "Shanghai Ninth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liuliu Feng', 'role': 'CONTACT'}], 'facility': 'Shanghai Shidong Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chengxing Shen', 'role': 'CONTACT'}], 'facility': "Shanghai Sixth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zening Shen', 'role': 'CONTACT'}], 'facility': 'Shanghai Tongren Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yawei Xu', 'role': 'CONTACT'}], 'facility': "Tenth People's Hospital of Tongji University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuebo Liu', 'role': 'CONTACT'}], 'facility': 'Tongji Hospital of Tongji University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Fan', 'role': 'CONTACT'}], 'facility': 'Yueyang hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuebin Han', 'role': 'CONTACT'}], 'facility': 'Shanxi cardiovascular hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dengfeng Ma', 'role': 'CONTACT'}], 'facility': 'Taiyuan central hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yin Liu', 'role': 'CONTACT'}], 'facility': 'Tianjin Chest Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Karamay', 'state': 'Xinjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaohong Liu', 'role': 'CONTACT'}], 'facility': 'Karamay Central Hospital', 'geoPoint': {'lat': 45.58473, 'lon': 84.88724}}, {'city': 'Kunming', 'state': 'Yunnan', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': "Yan'an Hospital of Kunming City", 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianan Wang', 'role': 'CONTACT'}], 'facility': 'Second Affiliated Hospital of Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhenjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guohui Zhang', 'role': 'CONTACT'}], 'facility': "Zhenjiang First People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Kang Yao, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'yao.kang@zs-hospital.sh.cn', 'phone': '86+13818988550'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Junbo Ge', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}