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.

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2018-04
• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-04-28
• Last Update Submitted: 2018-04-28
• Study First Posted: 2018-05-11
• Last Update Posted: 2018-05-11
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

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

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (19)

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

Daping Hospital; 🇨🇳 Chongqing, Chongqing, China

The Second Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, 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

Scroll for more (9 remaining)