- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02569268
Beijing Vascular Disease Patients Evaluation STudy (BEST)
Early Vascular Disease Detection System for High Risk Patients in Beijing
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
- Detection of vascular function indicators include: PWV, IMT, CFVR, FMD, CAVI, ABI, LDL-C, HOMA-IR, hs-CRP, Hcy, BNP, UA and so on.
- Design the questionnaire: surveying the lifestyle, personal history, family history of the study population.
- 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.
- 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).
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- health subjects with or without history of vascular-related diseases; or
- hypertension subjects; or
- diabetes mellitus subjects; or
- coronary artery disease; or
- cerebrovascular disease;or
- hyperlipidemia subjects.
Exclusion Criteria:
- severe infectious diseases and inflammatory diseases;
- liver and kidney failure;
- cancer;
- immunological diseases;
- hematological system diseases。
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
exposure population
No special intervention(s) .
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of vascular diseases-related death
Time Frame: Up to 1 year
|
Up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of acute coronary syndrome
Time Frame: Up to 1 year
|
After follow-up and questionnaire, to clear the diagnosis of acute coronary syndrome assessed by guideline or CTCAE v4.0(Grade 3-5).
|
Up to 1 year
|
Number of acute stroke
Time Frame: Up to 1 year
|
After follow-up and questionnaire, to clear the diagnosis of acute cerebral infarction and cerebral hemorrhage assessed by guideline.
|
Up to 1 year
|
Number of acute heart failure
Time Frame: Up to 1 year
|
After follow-up and questionnaire, to clear the diagnosis of acute heart failure assessed by guideline or CTCAE v4.0(Grade 3-5).
|
Up to 1 year
|
Number of peripheral arteriosclerosis occlusion
Time Frame: Up to 1 year
|
After follow-up and questionnaire, to clear the diagnosis of peripheral ischemia by guideline or CTCAE v4.0(Grade 3-5).
|
Up to 1 year
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Kietadisorn R, Kietselaer BL, Schmidt HH, Moens AL. Role of tetrahydrobiopterin (BH4) in hyperhomocysteinemia-induced endothelial dysfuction: new indication for this orphan-drug? Am J Physiol Endocrinol Metab. 2011 Jun;300(6):E1176; author reply E1177-8. doi: 10.1152/ajpendo.00084.2011. Epub 2011 Mar 22. No abstract available.
- 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. Erratum In: J Hypertens. 2007 Aug;25(8):1749.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hongyu Wang
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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