Association of Synchronous Four-limb blOod pRessure and Pulse Wave velocIty With Cardiovascular Events (ASORPWICE)

April 28, 2018 updated by: Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital

A National Registry for the Association of Synchronous Four-limb Blood Pressure and Pulse Wave Velocity With Cardiovascular Events in China

A multicenter prospective registry planned to recruit more than 100 000 patients 50 years old and older was carried out in China. This primary purpose of this study was to evaluate the association of synchronous four-limb blood pressure and pulse wave velocity with cardiovascular events. The secondary purpose was to evaluate the incidence rate,prevalence rate, value of diagnosis for peripheral arterial occlusive disease, and to follow up the effects of revascularization on cardiovascular events.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Although many studies with the correlation between synchronous four-limb blood pressure and pulse velocity measurement and cardiovascular outcomes have existed currently, the sample sizes are relatively small and the data on Chinese populations are lacking.Therefore, a multicenter prospective registry planned to recruit more than 100 000 patients aged 50 years old and older was carried out in China. This primary purpose of this study was to evaluate the association of synchronous four-limb blood pressure and pulse wave velocity with cardiovascular events in chinese populations. The secondary purpose was to evaluate the incidence rate,prevalence rate, value of diagnosis for peripheral arterial occlusive disease, and to follow up the effects of revascularization on cardiovascular events.

Study Type

Observational

Enrollment (Anticipated)

100000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 010
        • Not yet recruiting
        • Beijing Renhe Hospital
        • Contact:
      • Beijing, Beijing, China, 010
        • Not yet recruiting
        • Chinese PLA General Hospital
      • Beijing, Beijing, China, 010
        • Recruiting
        • Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
    • Chongqing
      • Chongqing, Chongqing, China, 023
        • Not yet recruiting
        • Daping Hospital
      • Chongqing, Chongqing, China, 023
        • Not yet recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Jin Huang, MD
    • Gansu
      • Lanzhou, Gansu, China, 0931
        • Not yet recruiting
        • Lanzhou University Second Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 020
        • Not yet recruiting
        • Guangdong General Hospital
      • Shenzhen, Guangdong, China, 0755
        • Not yet recruiting
        • The Eighth Affiliated Hospital of Sun Yat-Sen University
    • Hebei
      • Tangshan, Hebei, China, 0315
        • Not yet recruiting
        • Kailuan general hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 0791
        • Not yet recruiting
        • The First Affiliated Hospital of Nanchang University
      • Nanchang, Jiangxi, China, 0791
        • Not yet recruiting
        • The Second Affiliated Hospital of Nanchang University
    • Liaoning
      • Shenyang, Liaoning, China, 024
        • Not yet recruiting
        • The General Hospital of Shenyang Military
    • Shanghai
      • Shanghai, Shanghai, China, 021
        • Not yet recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
      • Shanghai, Shanghai, China, 021
        • Not yet recruiting
        • Shanghai East Hospital
        • Contact:
          • Qi Zhang, MD
    • Shanxi
      • Taiyuan, Shanxi, China, 0351
        • Not yet recruiting
        • Shanxi Cardiovascular Hospital
      • Xi'an, Shanxi, China, 029
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, Shanxi, China, 029
        • Not yet recruiting
        • Xi'an No.3 Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 028
        • Not yet recruiting
        • West China Hospital of Sichuan University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 0571
        • Not yet recruiting
        • Zhejiang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chinese populations with age ≥ 50 years old at the time of informed consent in hospital, community and physical examination center

Description

Inclusion Criteria:

  1. Age ≥ 50 years old at the time of informed consent
  2. Chinese populations in hospital, community and physical examination center

Exclusion Criteria:

  1. Patients with lack of limb,malformation of limbs, severe limb trauma or infection.
  2. Serious organic disease affecting the quality of life, such as tumors, massive cerebral infarction, uremia, and etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of cardiovascular events (cardiovascular death,myocardial infarction, heart failure, stroke, renal failure, aortic dissection)
Time Frame: From date of enrollment until the date of first documented cardiovascular events or date of death from any cause, whichever came first, assessed up to 12 months
From date of enrollment until the date of first documented cardiovascular events or date of death from any cause, whichever came first, assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of cardiovascular events (cardiovascular death,myocardial infarction, heart failure, stroke, renal failure, aortic dissection)
Time Frame: Measured at 6 months, 24 months and every 12 months thereafter from date of enrollment until the date of first documented cardiovascular events or date of death from any cause, whichever came first, assessed up to 60 months
Measured at 6 months, 24 months and every 12 months thereafter from date of enrollment until the date of first documented cardiovascular events or date of death from any cause, whichever came first, assessed up to 60 months
Incidence of death from any cause
Time Frame: Measured at 6 months, 12 months and every 12 months thereafter from date of enrollment until the date of first documented death from any cause, assessed up to 60 months
Measured at 6 months, 12 months and every 12 months thereafter from date of enrollment until the date of first documented death from any cause, assessed up to 60 months
Incidence of peripheral arterial disease
Time Frame: Measured at 6 months, 12 months and every 12 months thereafter from date of enrollment until the date of first documented four-limb peripheral arterial disease or date of death from any cause, whichever came first, assessed up to 60 months
Measured at 6 months, 12 months and every 12 months thereafter from date of enrollment until the date of first documented four-limb peripheral arterial disease or date of death from any cause, whichever came first, assessed up to 60 months
Incidence of limb gangrene
Time Frame: Measured at 6 months, 12 months and every 12 months thereafter from date of enrollment until the date of first documented gangrene caused by peripheral arterial disease or date of death from any cause,whichever came first, assessed up to 60 months
Measured at 6 months, 12 months and every 12 months thereafter from date of enrollment until the date of first documented gangrene caused by peripheral arterial disease or date of death from any cause,whichever came first, assessed up to 60 months
Incidence of amputation
Time Frame: Measured at 6 months, 12 months and every 12 months thereafter from date of enrollment until the date of first documented amputation caused by peripheral arterial disease or date of death from any cause, whichever came first, assessed up to 60 months
Measured at 6 months, 12 months and every 12 months thereafter from date of enrollment until the date of first documented amputation caused by peripheral arterial disease or date of death from any cause, whichever came first, assessed up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

April 11, 2018

First Submitted That Met QC Criteria

April 28, 2018

First Posted (Actual)

May 11, 2018

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

April 28, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018-993

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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