NCT02569268

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 10, 2016

Status Verified

May 1, 2016

Enrollment Period

3.9 years

First QC Date

September 30, 2015

Last Update Submit

May 7, 2016

Conditions

Keywords

ArteriosclerosisVascular functionVascular disease early detection system

Outcome Measures

Primary Outcomes (1)

  • Number of vascular diseases-related death

    Up to 1 year

Secondary Outcomes (4)

  • Number of acute coronary syndrome

    Up to 1 year

  • Number of acute stroke

    Up to 1 year

  • Number of acute heart failure

    Up to 1 year

  • Number of peripheral arteriosclerosis occlusion

    Up to 1 year

Study Arms (1)

exposure population

No special intervention(s) .

Other: Questionnaires and follow-up

Interventions

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.

exposure population

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • health subjects with or without history of vascular-related diseases; or
  • hypertension subjects; or
  • diabetes mellitus subjects; or
  • coronary artery disease; or
  • cerebrovascular disease;or
  • hyperlipidemia subjects.

You may not qualify if:

  • severe infectious diseases and inflammatory diseases;
  • liver and kidney failure;
  • cancer;
  • immunological diseases;
  • hematological system diseases。

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    BACKGROUND
  • 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, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Erdine S, Kiowski W, Agabiti-Rosei E, Ambrosioni E, Lindholm LH, Viigimaa M, Adamopoulos S, Agabiti-Rosei E, Ambrosioni E, Bertomeu V, Clement D, Erdine S, Farsang C, Gaita D, Lip G, Mallion JM, Manolis AJ, Nilsson PM, O'Brien E, Ponikowski P, Redon J, Ruschitzka F, Tamargo J, van Zwieten P, Waeber B, Williams B; Management of Arterial Hypertension of the European Society of Hypertension; European Society of Cardiology. 2007 Guidelines for the Management of Arterial Hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2007 Jun;25(6):1105-87. doi: 10.1097/HJH.0b013e3281fc975a. No abstract available.

  • 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. doi: 10.1161/CIRCULATIONAHA.105.579342.

  • 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: 10.1016/j.jash.2011.05.001. Epub 2011 Jun 29.

  • 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. doi: 10.2337/dc06-1529. No abstract available.

  • 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;80(2):265-70. doi: 10.1016/j.diabres.2007.12.016. Epub 2008 Feb 1.

  • 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 Care. 2006 Mar;29(3):637-42. doi: 10.2337/diacare.29.03.06.dc05-1637.

  • 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.

  • 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 Dec;299(6):E1061-5. doi: 10.1152/ajpendo.00367.2010. Epub 2010 Sep 21.

  • Liu H, Liu J, Huang W, Zhao H, Zhao N, Wang H. Association between multi-site atherosclerotic plaques and systemic arteriosclerosis: results from the BEST study (Beijing Vascular Disease Patients Evaluation Study). Cardiovasc Ultrasound. 2020 Aug 1;18(1):30. doi: 10.1186/s12947-020-00212-3.

  • Liu H, Xie W, Liu J, Zhao H, Wu Y, Wang H. Comparison of vascular-related diseases in their associations with carotid femoral pulse wave velocity: From the Beijing Vascular Disease Patients Evaluation Study (BEST Study). Int J Clin Pract. 2019 Nov;73(11):e13400. doi: 10.1111/ijcp.13400. Epub 2019 Aug 19.

  • Lan Y, Liu H, Liu J, Zhao H, Wang H. Gender Difference of the Relationship between Arterial Stiffness and Blood Pressure Variability in Participants in Prehypertension. Int J Hypertens. 2019 Jun 25;2019:7457385. doi: 10.1155/2019/7457385. eCollection 2019.

  • Zhao XX, Liu J, Zhao H, Zhou Y, Li L, Wang H. The effect of cardiovascular risk factors on the carotid intima-media thickness in an old-aged cohort with hypertension: a longitudinal evolution with 4-year follow-up of a random clinical trial. Clin Exp Hypertens. 2019;41(1):49-57. doi: 10.1080/10641963.2018.1441860. Epub 2018 Mar 19.

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample for DNA examination

MeSH Terms

Conditions

Vascular DiseasesArteriosclerosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director and Professor of Vascular Medicine

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 6, 2015

Study Start

January 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 10, 2016

Record last verified: 2016-05