Beijing Vascular Disease Patients Evaluation STudy

Completed

• Conditions: Vascular Disease
• Interventions: Other: Questionnaires and follow-up

• Registration Number: NCT02569268
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-06
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-07
• Last Update Posted: 2016-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
exposure population	Questionnaires and follow-up	No special intervention(s) .

Primary Outcome Measures

Name	Time	Method
Number of vascular diseases-related death	Up to 1 year

Secondary Outcome Measures

Name	Time	Method
Number of acute heart failure	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).
Number of acute coronary syndrome	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).
Number of peripheral arteriosclerosis occlusion	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).
Number of acute stroke	Up to 1 year	After follow-up and questionnaire, to clear the diagnosis of acute cerebral infarction and cerebral hemorrhage assessed by guideline.