Clinical trial NCT03521739: Association of Synchronous Four-limb blOod pRessure and Pulse Wave velocIty With Cardiovascular Events
Official title: A National Registry for the Association of Synchronous Four-limb Blood Pressure and Pulse Wave Velocity With Cardiovascular Events in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Pressure
Pulse Wave Analysis
Ankle Brachial Index
Patient Outcome Assessment
Keywords: blood pressure
pulse wave velocity
ankle brachial index
cardiovascular events
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 100000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of cardiovascular events (cardiovascular death,myocardial infarction, heart failure, stroke, renal failure, aortic dissection)
timeFrame: 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:
measure: Incidence of cardiovascular events (cardiovascular death,myocardial infarction, heart failure, stroke, renal failure, aortic dissection)
timeFrame: 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
measure: Incidence of death from any cause
timeFrame: 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
measure: Incidence of peripheral arterial disease
timeFrame: 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
measure: Incidence of limb gangrene
timeFrame: 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
measure: Incidence of amputation
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Renhe Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
city: Chongqing
country: China
facility: Daping Hospital
state: Chongqing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Shenzhen
country: China
facility: The Eighth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Tangshan
country: China
facility: Kailuan General Hospital
state: Hebei
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shenyang
country: China
facility: The General Hospital of Shenyang Military
state: Liaoning
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Cardiovascular Hospital
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: Xi'an NO.3 Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang Hospital
state: Zhejiang
Study officials:
affiliation: Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
name: Xiongjing Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.