Beijing Vascular Disease Patients Evaluation STudy

Vascular Disease Clinical Trial

— BEST  

Official title:

Early Vascular Disease Detection System for High Risk Patients in Beijing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569268
• Other study ID #: Hongyu Wang
• Status: Completed
• Phase: N/A
• First received: September 30, 2015
• Last updated: May 5, 2016
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: Peking University Shougang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Vascular Disease
• Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Shougang Hospital	Beijing Municipal Health Bureau

References & Publications (9)

Antoniades C, Antonopoulos AS, Tousoulis D, Marinou K, Stefanadis C. Homocysteine and coronary atherosclerosis: from folate fortification to the recent clinical trials. Eur Heart J. 2009 Jan;30(1):6-15. doi: 10.1093/eurheartj/ehn515. Epub 2008 Nov 23. Rev — View Citation

Duprez DA, Florea N, Zhong W, Grandits GA, Hawthorne CK, Hoke L, Cohn JN. Vascular and cardiac functional and structural screening to identify risk of future morbid events: preliminary observations. J Am Soc Hypertens. 2011 Sep-Oct;5(5):401-9. doi: 10.101 — View Citation

He L, Zeng H, Li F, Feng J, Liu S, Liu J, Yu J, Mao J, Hong T, Chen AF, Wang X, Wang G. Homocysteine impairs coronary artery endothelial function by inhibiting tetrahydrobiopterin in patients with hyperhomocysteinemia. Am J Physiol Endocrinol Metab. 2010 — View Citation

Hirata K, Kadirvelu A, Di Tullio M, Homma S, Choy AM, Lang CC. Coronary vasomotor function is abnormal in first-degree relatives of patients with type 2 diabetes. Diabetes Care. 2007 Jan;30(1):150-3. — View Citation

Ibata J, Sasaki H, Kakimoto T, Matsuno S, Nakatani M, Kobayashi M, Tatsumi K, Nakano Y, Wakasaki H, Furuta H, Nishi M, Nanjo K. Cardio-ankle vascular index measures arterial wall stiffness independent of blood pressure. Diabetes Res Clin Pract. 2008 May;8 — View Citation

Mancia G, De Backer G, Dominiczak A, Cifkova R, Fagard R, Germano G, Grassi G, Heagerty AM, Kjeldsen SE, Laurent S, Narkiewicz K, Ruilope L, Rynkiewicz A, Schmieder RE, Boudier HA, Zanchetti A, Vahanian A, Camm J, De Caterina R, Dean V, Dickstein K, Filip — View Citation

Wang G, He L,Hong T.Reply to letter to the editor: coronary flow velocity reserve was impaired in chronic hyperhomocysteinemia patients:why?Am J Physiol Endocrinol Metab.2011,300:E1177-E1178.

Wild SH, Byrne CD, Smith FB, Lee AJ, Fowkes FG. Low ankle-brachial pressure index predicts increased risk of cardiovascular disease independent of the metabolic syndrome and conventional cardiovascular risk factors in the Edinburgh Artery Study. Diabetes — View Citation

Willum-Hansen T, Staessen JA, Torp-Pedersen C, Rasmussen S, Thijs L, Ibsen H, Jeppesen J. Prognostic value of aortic pulse wave velocity as index of arterial stiffness in the general population. Circulation. 2006 Feb 7;113(5):664-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of vascular diseases-related death		Up to 1 year	Yes
Secondary	Number of acute coronary syndrome	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	Yes
Secondary	Number of acute stroke	After follow-up and questionnaire, to clear the diagnosis of acute cerebral infarction and cerebral hemorrhage assessed by guideline.	Up to 1 year	Yes
Secondary	Number of acute heart failure	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	Yes
Secondary	Number of peripheral arteriosclerosis occlusion	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	Yes