Beijing Vascular Disease Patients Evaluation STudy (BEST)

May 7, 2016 updated by: Hongyu Wang, Peking University Shougang Hospital

Early Vascular Disease Detection System for High Risk Patients in Beijing

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.

Study Overview

Status

Completed

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.

  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).

Study Type

Observational

Enrollment (Anticipated)

2000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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。

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

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

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Shougang Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 30, 2015

First Submitted That Met QC Criteria

October 2, 2015

First Posted (Estimate)

October 6, 2015

Study Record Updates

Last Update Posted (Estimate)

May 10, 2016

Last Update Submitted That Met QC Criteria

May 7, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

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.

Clinical Trials on Vascular Disease

Clinical Trials on Questionnaires and follow-up

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe