Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-25 @ 3:37 AM
Study NCT ID:
NCT02569268
Status:
COMPLETED
Last Update Posted:
2016-05-10
First Post:
2015-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Beijing Vascular Disease Patients Evaluation STudy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood sample for DNA examination'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-07', 'studyFirstSubmitDate': '2015-09-30', 'studyFirstSubmitQcDate': '2015-10-02', 'lastUpdatePostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of vascular diseases-related death', 'timeFrame': 'Up to 1 year'}], 'secondaryOutcomes': [{'measure': 'Number of acute coronary syndrome', 'timeFrame': 'Up to 1 year', 'description': 'After follow-up and questionnaire, to clear the diagnosis of acute coronary syndrome assessed by guideline or CTCAE v4.0（Grade 3-5).'}, {'measure': 'Number of acute stroke', 'timeFrame': 'Up to 1 year', 'description': 'After follow-up and questionnaire, to clear the diagnosis of acute cerebral infarction and cerebral hemorrhage assessed by guideline.'}, {'measure': 'Number of acute heart failure', 'timeFrame': 'Up to 1 year', 'description': 'After follow-up and questionnaire, to clear the diagnosis of acute heart failure assessed by guideline or CTCAE v4.0（Grade 3-5).'}, {'measure': 'Number of peripheral arteriosclerosis occlusion', 'timeFrame': 'Up to 1 year', 'description': 'After follow-up and questionnaire, to clear the diagnosis of peripheral ischemia by guideline or CTCAE v4.0（Grade 3-5).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Arteriosclerosis', 'Vascular function', 'Vascular disease early detection system'], 'conditions': ['Vascular Disease']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Wang G， He L，Hong T.Reply to letter to the editor: coronary flow velocity reserve was impaired in chronic hyperhomocysteinemia patients：why?Am J Physiol Endocrinol Metab.2011，300：E1177-E1178.'}, {'pmid': '17563527', 'type': 'RESULT', 'citation': "Mancia G, De Backer G, Dominiczak A, Cifkova R, Fagard R, Germano G, Grassi G, Heagerty AM, Kjeldsen SE, Laurent S, Narkiewicz K, Ruilope L, Rynkiewicz A, Schmieder RE, Boudier HA, Zanchetti A, Vahanian A, Camm J, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Erdine S, Kiowski W, Agabiti-Rosei E, Ambrosioni E, Lindholm LH, Viigimaa M, Adamopoulos S, Agabiti-Rosei E, Ambrosioni E, Bertomeu V, Clement D, Erdine S, Farsang C, Gaita D, Lip G, Mallion JM, Manolis AJ, Nilsson PM, O'Brien E, Ponikowski P, Redon J, Ruschitzka F, Tamargo J, van Zwieten P, Waeber B, Williams B; Management of Arterial Hypertension of the European Society of Hypertension; European Society of Cardiology. 2007 Guidelines for the Management of Arterial Hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2007 Jun;25(6):1105-87. doi: 10.1097/HJH.0b013e3281fc975a. No abstract available."}, {'pmid': '16461839', 'type': 'RESULT', 'citation': 'Willum-Hansen T, Staessen JA, Torp-Pedersen C, Rasmussen S, Thijs L, Ibsen H, Jeppesen J. Prognostic value of aortic pulse wave velocity as index of arterial stiffness in the general population. Circulation. 2006 Feb 7;113(5):664-70. doi: 10.1161/CIRCULATIONAHA.105.579342.'}, {'pmid': '21719371', 'type': 'RESULT', 'citation': 'Duprez DA, Florea N, Zhong W, Grandits GA, Hawthorne CK, Hoke L, Cohn JN. Vascular and cardiac functional and structural screening to identify risk of future morbid events: preliminary observations. J Am Soc Hypertens. 2011 Sep-Oct;5(5):401-9. doi: 10.1016/j.jash.2011.05.001. Epub 2011 Jun 29.'}, {'pmid': '17192351', 'type': 'RESULT', 'citation': 'Hirata K, Kadirvelu A, Di Tullio M, Homma S, Choy AM, Lang CC. Coronary vasomotor function is abnormal in first-degree relatives of patients with type 2 diabetes. Diabetes Care. 2007 Jan;30(1):150-3. doi: 10.2337/dc06-1529. No abstract available.'}, {'pmid': '18242761', 'type': 'RESULT', 'citation': 'Ibata J, Sasaki H, Kakimoto T, Matsuno S, Nakatani M, Kobayashi M, Tatsumi K, Nakano Y, Wakasaki H, Furuta H, Nishi M, Nanjo K. Cardio-ankle vascular index measures arterial wall stiffness independent of blood pressure. Diabetes Res Clin Pract. 2008 May;80(2):265-70. doi: 10.1016/j.diabres.2007.12.016. Epub 2008 Feb 1.'}, {'pmid': '16505519', 'type': 'RESULT', 'citation': 'Wild SH, Byrne CD, Smith FB, Lee AJ, Fowkes FG. Low ankle-brachial pressure index predicts increased risk of cardiovascular disease independent of the metabolic syndrome and conventional cardiovascular risk factors in the Edinburgh Artery Study. Diabetes Care. 2006 Mar;29(3):637-42. doi: 10.2337/diacare.29.03.06.dc05-1637.'}, {'pmid': '19029125', 'type': 'RESULT', 'citation': 'Antoniades C, Antonopoulos AS, Tousoulis D, Marinou K, Stefanadis C. Homocysteine and coronary atherosclerosis: from folate fortification to the recent clinical trials. Eur Heart J. 2009 Jan;30(1):6-15. doi: 10.1093/eurheartj/ehn515. Epub 2008 Nov 23.'}, {'pmid': '20858749', 'type': 'RESULT', 'citation': 'He L, Zeng H, Li F, Feng J, Liu S, Liu J, Yu J, Mao J, Hong T, Chen AF, Wang X, Wang G. Homocysteine impairs coronary artery endothelial function by inhibiting tetrahydrobiopterin in patients with hyperhomocysteinemia. Am J Physiol Endocrinol Metab. 2010 Dec;299(6):E1061-5. doi: 10.1152/ajpendo.00367.2010. Epub 2010 Sep 21.'}, {'pmid': '32738905', 'type': 'DERIVED', 'citation': 'Liu H, Liu J, Huang W, Zhao H, Zhao N, Wang H. Association between multi-site atherosclerotic plaques and systemic arteriosclerosis: results from the BEST study (Beijing Vascular Disease Patients Evaluation Study). Cardiovasc Ultrasound. 2020 Aug 1;18(1):30. doi: 10.1186/s12947-020-00212-3.'}, {'pmid': '31390128', 'type': 'DERIVED', 'citation': 'Liu H, Xie W, Liu J, Zhao H, Wu Y, Wang H. Comparison of vascular-related diseases in their associations with carotid femoral pulse wave velocity: From the Beijing Vascular Disease Patients Evaluation Study (BEST Study). Int J Clin Pract. 2019 Nov;73(11):e13400. doi: 10.1111/ijcp.13400. Epub 2019 Aug 19.'}, {'pmid': '31341663', 'type': 'DERIVED', 'citation': 'Lan Y, Liu H, Liu J, Zhao H, Wang H. Gender Difference of the Relationship between Arterial Stiffness and Blood Pressure Variability in Participants in Prehypertension. Int J Hypertens. 2019 Jun 25;2019:7457385. doi: 10.1155/2019/7457385. eCollection 2019.'}, {'pmid': '29553852', 'type': 'DERIVED', 'citation': 'Zhao XX, Liu J, Zhao H, Zhou Y, Li L, Wang H. The effect of cardiovascular risk factors on the carotid intima-media thickness in an old-aged cohort with hypertension: a longitudinal evolution with 4-year follow-up of a random clinical trial. Clin Exp Hypertens. 2019;41(1):49-57. doi: 10.1080/10641963.2018.1441860. Epub 2018 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'Arteriosclerotic vascular-related diseases have become a serious threat to human health. The prevention and reversal of vascular events has become an important direction of medicine. Early vascular disease detection system includes pulse wave velocity (PWV), carotid intima-media thickness (IMT) and coronary flow velocity reserve (CFVR), flow-mediated vasodilation (FMD), cardio-ankle vascular index (CAVI), ankle-brachial index (ABI), insulin resistance index (HOMA-IR), hypersensitivity C- reactive protein (hs-CRP), plasma homocysteine (Hcy), B-type natriuretic peptide (BNP), uric acid (UA), and so on. However, there is no international and domestic comprehensive study on simple and practical evaluation system by jointing application of these evaluation indexes to detect vascular disease. Combined evaluation function can simultaneously detect and evaluate vascular abnormalities, make up a single indicator shortcoming in clinical applications from multiple levels of vascular structure and function. However, all indicators testing not only cause time consuming, but also increase the burden on patients, resulting unnecessary waste of medical resources. Thus, the present study was to select appropriate indicators and effective joint, and establish the rating system, using the vascular system to predict the incidence of terminal events, and compare this system with the previous scoring system such as FRS (Framingham Risk Score) pros and cons.', 'detailedDescription': 'This study aimed to establish vascular disease early detection system and scoring systems by comprehensive vascular disease risk factors and vascular function evaluation index. And prevention of vascular-related diseases, high-risk groups through positive lifestyle changes: such as lipid-lowering, smoking cessation, reversing early vascular lesions, to avoid end-stage vascular events.\n\n1. Detection of vascular function indicators include: PWV, IMT, CFVR, FMD, CAVI, ABI, LDL-C, HOMA-IR, hs-CRP, Hcy, BNP, UA and so on.\n2. Design the questionnaire: surveying the lifestyle, personal history, family history of the study population.\n3. Follow-up:2 years of observation, recording the end time of vascular events, including cardiovascular events (acute myocardial infarction, angina, coronary reperfusion therapy), stroke, heart failure, peripheral vascular disease.\n4. Statistics: Complex the factors of vascular disease, screen for an effective indicator to predict cardiovascular events, and based on the weight of the different factors, the establish the rating system, use the system to predict the incidence of vascular events terminal, and compare the system with the previous scoring system such as FRS (Framingham Risk Score).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects such as patient or inpatient patients , aged 45-75 years ,in high-risk vascular events groups ,and from Dongcheng District, Shijingshan Shougang community and Mentougou District.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. health subjects with or without history of vascular-related diseases; or\n2. hypertension subjects; or\n3. diabetes mellitus subjects; or\n4. coronary artery disease; or\n5. cerebrovascular disease;or\n6. hyperlipidemia subjects.\n\nExclusion Criteria:\n\n1. severe infectious diseases and inflammatory diseases;\n2. liver and kidney failure;\n3. cancer;\n4. immunological diseases;\n5. hematological system diseases。'}, 'identificationModule': {'nctId': 'NCT02569268', 'acronym': 'BEST', 'briefTitle': 'Beijing Vascular Disease Patients Evaluation STudy', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Shougang Hospital'}, 'officialTitle': 'Early Vascular Disease Detection System for High Risk Patients in Beijing', 'orgStudyIdInfo': {'id': 'Hongyu Wang'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'exposure population', 'description': 'No special intervention(s) .', 'interventionNames': ['Other: Questionnaires and follow-up']}], 'interventions': [{'name': 'Questionnaires and follow-up', 'type': 'OTHER', 'description': 'Detecting the vascular functional parameters, questionnaire and follow-up: For 2 years or the occurrence of vascular events end time, including cardiovascular events (acute myocardial infarction, angina, coronary reperfusion therapy), stroke, heart failure, peripheral vascular disease.', 'armGroupLabels': ['exposure population']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Shougang Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University Third Hospital', 'class': 'OTHER'}, {'name': 'Peking University Health Science Center', 'class': 'OTHER'}, {'name': 'Beijing Municipal Science & Technology Commission', 'class': 'OTHER'}, {'name': 'Chinese National Natural Science Foundation Commission', 'class': 'UNKNOWN'}, {'name': 'Ministry of Education, China', 'class': 'OTHER_GOV'}, {'name': 'National Health and Family Planning Commission of the China', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director and Professor of Vascular Medicine', 'investigatorFullName': 'Hongyu Wang', 'investigatorAffiliation': 'Peking University Shougang Hospital'}}}}