NCT03521739

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

19 active sites

Status
unknown

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, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 11, 2018

Status Verified

April 1, 2018

Enrollment Period

5 years

First QC Date

April 11, 2018

Last Update Submit

April 28, 2018

Conditions

Keywords

blood pressurepulse wave velocityankle brachial indexcardiovascular events

Outcome Measures

Primary Outcomes (1)

  • Incidence of cardiovascular events (cardiovascular death,myocardial infarction, heart failure, stroke, renal failure, aortic dissection)

    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 Outcomes (5)

  • Incidence of cardiovascular events (cardiovascular death,myocardial infarction, heart failure, stroke, renal failure, aortic dissection)

    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

    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

    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

    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

    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

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Beijing Renhe Hospital

Beijing, Beijing Municipality, 010, China

NOT YET RECRUITING

Chinese PLA General Hospital

Beijing, Beijing Municipality, 010, China

NOT YET RECRUITING

Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 010, China

RECRUITING

Daping Hospital

Chongqing, Chongqing Municipality, 023, China

NOT YET RECRUITING

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 023, China

NOT YET RECRUITING

Lanzhou University Second Hospital

Lanzhou, Gansu, 0931, China

NOT YET RECRUITING

Guangdong General Hospital

Guangzhou, Guangdong, 020, China

NOT YET RECRUITING

The Eighth Affiliated Hospital of Sun Yat-sen University

Shenzhen, Guangdong, 0755, China

NOT YET RECRUITING

Kailuan General Hospital

Tangshan, Hebei, 0315, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 0791, China

NOT YET RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 0791, China

NOT YET RECRUITING

The General Hospital of Shenyang Military

Shenyang, Liaoning, 024, China

NOT YET RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 021, China

NOT YET RECRUITING

Shanghai East Hospital

Shanghai, Shanghai Municipality, 021, China

NOT YET RECRUITING

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, 0351, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 029, China

NOT YET RECRUITING

Xi'an NO.3 Hospital

Xi’an, Shanxi, 029, China

NOT YET RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 028, China

NOT YET RECRUITING

Zhejiang Hospital

Hangzhou, Zhejiang, 0571, China

NOT YET RECRUITING

Related Publications (1)

  • An X, Dong H, Deng Y, Chen Y, Zou Y, Zhang W, Jiang X. Evaluation of the role of combining inter-arm systolic pressure difference and derivatives of pulse volume recording in detecting subclavian artery stenosis. Front Cardiovasc Med. 2022 Sep 15;9:962610. doi: 10.3389/fcvm.2022.962610. eCollection 2022.

Study Officials

  • Xiongjing Jiang, MD

    Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiongjing Jiang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 11, 2018

First Posted

May 11, 2018

Study Start

January 1, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

May 11, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations