Blood PressureASORPWICENCT03521739
Association of Synchronous Four-limb blOod pRessure and Pulse Wave velocIty With Cardiovascular Events
An observational study of Blood Pressure and Pulse Wave Analysis, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 19 sites in China.
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. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Pulse Wave Analysis, Ankle Brachial Index
- How many people
- 100,000 participants
- Where
- 19 sitesChina
- Study dates
- 1 Jan 2018to 31 Dec 2023
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chinese populations with age ≥ 50 years old at the time of informed consent in hospital, community and physical examination center
Who may be able to join
- Age ≥ 50 years old at the time of informed consent
- Chinese populations in hospital, community and physical examination center
Who cannot join
- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
China19 sites, 19 recruiting
- Not yet recruiting
Beijing Renhe Hospital
Beijing, Beijing Municipality, 010
Yan Li, MD, 86-010-69242469, 654562304@qq.com
- Not yet recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 010
Yu Wang, MD
- Recruiting
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 010
Xiongjing Jiang, MD, 86-1088322385, jxj103@hotmail.com
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 028
Xiaoping Chen, MD, 86-028-85422114, chenxp13@aliyun.com
- Not yet recruiting
Daping Hospital
Chongqing, Chongqing Municipality, 023
Zhigang Zhao, MD, 86-023-68811229, zhaozgsir@126.com
- Not yet recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 023
Jin Huang, MD
- Not yet recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 020
Jianfang Luo, MD, 86-020-83827812, henryjfl@tom.com
- Not yet recruiting
Zhejiang Hospital
Hangzhou, Zhejiang, 0571
Lijiang Tang, MD, 86-0571-87987373, lxw_76@163.com
- Not yet recruiting
Lanzhou University Second Hospital
Lanzhou, Gansu, 0931
Jing Yu, MD, 86-0931-8942262, yujing2304@126.com
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 0791
Zeqi Zheng, MD, 86-0791-88692748, zeqizheng@126.com
- Not yet recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 0791
Ping Li, MD, 86-0791-86297662, lipingsydney@163.com
- Not yet recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 021
Jianzhong Xu, MD, 86-021-64370045, jianzhongxv@gmail.com
- Not yet recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 021
Qi Zhang, MD
- Not yet recruiting
The General Hospital of Shenyang Military
Shenyang, Liaoning, 024
Xiaozeng Wang, MD, 86-024-28886666, wxiaozeng@163.com
- Not yet recruiting
The Eighth Affiliated Hospital of Sun Yat-sen University
Shenzhen, Guangdong, 0755
Nan Jia, MD, 86-0755-83982222, jiananchina@hotmail.com
- Not yet recruiting
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, 0351
Bin Yang, MD, 86-0351-5661145, yangbxys@163.com
- Not yet recruiting
Kailuan General Hospital
Tangshan, Hebei, 0315
Shouling Wu, MD, drwusl@163.com
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 029
Hongyan Tian, MD, 86-029-85252580, tianhhyy@mail.xjtu.edu.cn
- Not yet recruiting
Xi'an NO.3 Hospital
Xi’an, Shanxi, 029
Kang Cheng, MD, 86-029-61895566, chengkang2009@foxmail.com
About this study
Official title: A National Registry for the Association of Synchronous Four-limb Blood Pressure and Pulse Wave Velocity With Cardiovascular Events in China
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.
Read the 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.
- Keywords
- blood pressure, pulse wave velocity, ankle brachial index, cardiovascular events
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cardiovascular events (cardiovascular death,myocardial infarction, heart failure, stroke, renal failure, aortic dissection)
Measured: 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: 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: 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: 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: 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: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Xiongjing Jiang, MD, Principal investigator, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521739
- Sponsor's protocol ID
- 2018-993
- Acronym
- ASORPWICE
- Status last verified
- Apr 2018
- First submitted
- 11 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36186962
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National Registry for the Association of Synchronous Four-limb Blood Pressure and Pulse Wave Velocity With Cardiovascular Events in China
- ClinicalTrials.gov ID
- NCT03521739
- Acronym / sponsor ID
- ASORPWICE / 2018-993
- Keywords
- blood pressure, pulse wave velocity, ankle brachial index, cardiovascular events
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese populations with age ≥ 50 years old at the time of informed consent in hospital, community and physical examination center
Key inclusion criteria (2 listed)
- Age ≥ 50 years old at the time of informed consent
- Chinese populations in hospital, community and physical examination center
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of cardiovascular events (cardiovascular death,myocardial infarction, heart failure, stroke, renal failure, aortic dissection)
Time frame: 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
5 secondary outcomes
Incidence of cardiovascular events (cardiovascular death,myocardial infarction, heart failure, stroke, renal failure, aortic dissection)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Derived from this study: PubMed 36186962An 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiongjing Jiang, MD principal investigator
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure and Pulse Wave Analysis, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 19 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiongjing Jiang, MD (86-1088322385, jxj103@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cardiovascular events (cardiovascular death,myocardial infarction, heart failure, stroke, renal failure, aortic dissection) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03521739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.