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

Blood Pressure Clinical Trial

— ASORPWICE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03521739
• Other study ID #: 2018-993
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2018
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Xiongjing Jiang, MD
• Phone: 86-1088322385
• Email: jxj103[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ankle Brachial Index
• Blood Pressure
• Patient Outcome Assessment
• Pulse Wave Analysis

Locations

Country	Name	City	State
China	Beijing Renhe Hospital	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Daping Hospital	Chongqing	Chongqing
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Guangdong General Hospital	Guangzhou	Guangdong
China	Zhejiang Hospital	Hangzhou	Zhejiang
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Shanghai East Hospital	Shanghai	Shanghai
China	The General Hospital of Shenyang Military	Shenyang	Liaoning
China	The Eighth Affiliated Hospital of Sun Yat-sen University	Shenzhen	Guangdong
China	Shanxi Cardiovascular Hospital	Taiyuan	Shanxi
China	Kailuan General Hospital	Tangshan	Hebei
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	Xi'an NO.3 Hospital	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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