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

Conditions
Pulse Wave Analysis
Blood Pressure
Ankle Brachial Index
Patient Outcome Assessment
Registration Number
NCT03521739
Lead Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
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.

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
100000
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
Incidence of death from any causeMeasured 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 diseaseMeasured 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 gangreneMeasured 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 amputationMeasured 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
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

Trial Locations

Locations (19)

Daping Hospital

🇨🇳

Chongqing, Chongqing, China

Beijing Renhe Hospital

🇨🇳

Beijing, Beijing, China

Lanzhou University Second Hospital

🇨🇳

Lanzhou, Gansu, China

Guangdong General Hospital

🇨🇳

Guangzhou, Guangdong, China

The Eighth Affiliated Hospital of Sun Yat-sen University

🇨🇳

Shenzhen, Guangdong, China

Kailuan General Hospital

🇨🇳

Tangshan, Hebei, China

The First Affiliated Hospital of Nanchang University

🇨🇳

Nanchang, Jiangxi, China

The Second Affiliated Hospital of Nanchang University

🇨🇳

Nanchang, Jiangxi, China

The General Hospital of Shenyang Military

🇨🇳

Shenyang, Liaoning, China

Xi'an NO.3 Hospital

🇨🇳

Xi'an, Shanxi, China

West China Hospital of Sichuan University

🇨🇳

Chengdu, Sichuan, China

Zhejiang Hospital

🇨🇳

Hangzhou, Zhejiang, China

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

🇨🇳

Beijing, Beijing, China

The Second Affiliated Hospital of Chongqing Medical University

🇨🇳

Chongqing, Chongqing, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

🇨🇳

Shanghai, Shanghai, China

Shanghai East Hospital

🇨🇳

Shanghai, Shanghai, China

Shanxi Cardiovascular Hospital

🇨🇳

Taiyuan, Shanxi, China

The First Affiliated Hospital of Xi'an Jiaotong University

🇨🇳

Xi'an, Shanxi, China

Chinese PLA General Hospital

🇨🇳

Beijing, Beijing, China

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