BEST: Beijing Vascular Disease Patients Evaluation STudy

• Sponsor: Peking University Shougang Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02569268
• Collaborator: Peking University Third Hospital (Other), Peking University Health Science Center (Other), Beijing Municipal Science & Technology Commission (Other), Chinese National Natural Science Foundation Commission (Other), Ministry of Education, China (Other), National Health and Family Planning Commission of the China (Other)
• Enrollment: 2,000
• Duration (Months): 47

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Disease	Other: Questionnaires and follow-up

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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 2000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Early Vascular Disease Detection System for High Risk Patients in Beijing
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Number of vascular diseases-related death [Up to 1 year]

Secondary Outcome Measures

1. 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).

2. 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.

3. 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).

4. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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。

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Kietadisorn R, Kietselaer BL, Schmidt HH, Moens AL. Role of tetrahydrobiopterin (BH4) in hyperhomocysteinemia-induced endothelial dysfuction: new indication for this orphan-drug? Am J Physiol Endocrinol Metab. 2011 Jun;300(6):E1176; author reply E1177-8. doi: 10.1152/ajpendo.00084.2011. Epub 2011 Mar 22.

• Responsible Party: Hongyu Wang, Director and Professor of Vascular Medicine, Peking University Shougang Hospital
• ClinicalTrials.gov Identifier: NCT02569268
• Other Study ID Numbers: Hongyu Wang
• First Posted: Oct 6, 2015
• Last Update Posted: May 10, 2016
• Last Verified: May 1, 2016

• Keywords provided by Hongyu Wang, Director and Professor of Vascular Medicine, Peking University Shougang Hospital: Arteriosclerosis; Vascular function; Vascular disease early detection system
• Additional relevant MeSH terms: Vascular Diseases

Study Results

No Results Posted as of May 10, 2016