Clinical trial NCT02569268: Beijing Vascular Disease Patients Evaluation STudy
Official title: Early Vascular Disease Detection System for High Risk Patients in Beijing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Disease
Keywords: Arteriosclerosis
Vascular function
Vascular disease early detection system
Lead sponsor: Peking University Shougang Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Third Hospital
name: Peking University Health Science Center
name: Beijing Municipal Science & Technology Commission
name: Chinese National Natural Science Foundation Commission
name: Ministry of Education, China
name: National Health and Family Planning Commission of the China
First posted: 2015-10-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility 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。

Primary outcomes:
measure: Number of vascular diseases-related death
timeFrame: Up to 1 year
Secondary outcomes:
measure: Number of acute coronary syndrome
timeFrame: Up to 1 year
measure: Number of acute stroke
timeFrame: Up to 1 year
measure: Number of acute heart failure
timeFrame: Up to 1 year
measure: Number of peripheral arteriosclerosis occlusion
timeFrame: Up to 1 year
Other outcomes:
Locations:
Study officials:
References:
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