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Completed

NCT Number: NCT02569268

Beijing Vascular Disease Patients Evaluation STudy

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.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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。

Treatment and study plan

Questionnaires and follow-up

Other

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 outcomes

  1. Number of vascular diseases-related death

    Time frame: Up to 1 year

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Peking University Shougang Hospital

Other

Collaborators

  • Beijing Municipal Science & Technology Commission
  • Chinese National Natural Science Foundation Commission
  • Ministry of Education, China
  • National Health and Family Planning Commission of the China
  • Peking University Health Science Center
  • Peking University Third Hospital

Registry information

Official study title

Early Vascular Disease Detection System for High Risk Patients in Beijing

Acronym: BEST

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 6, 2015
Registry last updated
May 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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