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Beijing Vascular Disease Patients Evaluation STudy

Early Vascular Disease Detection System for High Risk Patients in Beijing

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02569268
Acronym
BEST
Enrollment
2000
Registered
2015-10-06
Start date
2012-01-31
Completion date
2015-12-31
Last updated
2016-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Disease

Keywords

Arteriosclerosis, Vascular function, Vascular disease early detection system

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.

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).

Interventions

OTHERQuestionnaires 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.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes

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。

Design outcomes

Primary

MeasureTime frame
Number of vascular diseases-related deathUp to 1 year

Secondary

MeasureTime frameDescription
Number of acute coronary syndromeUp to 1 yearAfter follow-up and questionnaire, to clear the diagnosis of acute coronary syndrome assessed by guideline or CTCAE v4.0(Grade 3-5).
Number of acute strokeUp to 1 yearAfter follow-up and questionnaire, to clear the diagnosis of acute cerebral infarction and cerebral hemorrhage assessed by guideline.
Number of acute heart failureUp to 1 yearAfter follow-up and questionnaire, to clear the diagnosis of acute heart failure assessed by guideline or CTCAE v4.0(Grade 3-5).
Number of peripheral arteriosclerosis occlusionUp to 1 yearAfter follow-up and questionnaire, to clear the diagnosis of peripheral ischemia by guideline or CTCAE v4.0(Grade 3-5).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026