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Beijing Vascular Disease Patients Evaluation STudy (BEST)

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ClinicalTrials.gov Identifier: NCT02569268
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : May 10, 2016
Sponsor:
Collaborators:
Peking University Third Hospital
Peking University Health Science Center
Beijing Municipal Science & Technology Commission
Chinese National Natural Science Foundation Commission
Ministry of Education of the China
National Health and Family Planning Commission of the China
Information provided by (Responsible Party):
Hongyu Wang, Peking University Shougang Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Vascular Disease Other: Questionnaires and follow-up

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.

  1. Detection of vascular function indicators include: PWV, IMT, CFVR, FMD, CAVI, ABI, LDL-C, HOMA-IR, hs-CRP, Hcy, BNP, UA and so on.
  2. Design the questionnaire: surveying the lifestyle, personal history, family history of the study population.
  3. 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.
  4. 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).

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Early Vascular Disease Detection System for High Risk Patients in Beijing
Study Start Date : January 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
exposure population
No special intervention(s) .
Other: Questionnaires and follow-up
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.




Primary Outcome Measures :
  1. Number of vascular diseases-related death [ Time Frame: Up to 1 year ]

Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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).

  4. 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).


Biospecimen Retention:   Samples With DNA
Blood sample for DNA examination


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  1. health subjects with or without history of vascular-related diseases; or
  2. hypertension subjects; or
  3. diabetes mellitus subjects; or
  4. coronary artery disease; or
  5. cerebrovascular disease;or
  6. hyperlipidemia subjects.

Exclusion Criteria:

  1. severe infectious diseases and inflammatory diseases;
  2. liver and kidney failure;
  3. cancer;
  4. immunological diseases;
  5. hematological system diseases。

Additional Information:

Publications of Results:
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. Erratum in: J Hypertens. 2007 Aug;25(8):1749.

Other Publications:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hongyu Wang, Director and Professor of Vascular Medicine, Peking University Shougang Hospital
ClinicalTrials.gov Identifier: NCT02569268     History of Changes
Other Study ID Numbers: Hongyu Wang
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: May 2016

Keywords provided by Hongyu Wang, Peking University Shougang Hospital:
Arteriosclerosis
Vascular function
Vascular disease early detection system

Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases