Non-Invasive Aortic Ambulatory Blood Pressure Monitoring for The Detection of Target Organ Damage in The Chinese Population
NCT ID: NCT03154203
Last Updated: 2017-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
3000 participants
OBSERVATIONAL
2017-06-01
2021-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Registry Study on the "Action of Controlling Ambulatory Blood Pressure to Target in Ten Thousand Patients"
NCT03547856
Home Blood Pressure Intervention in the Community Trial
NCT05858944
Cardiovascular Risk Assessment and Dynamic Monitoring-based Prevention Trial
NCT05919056
Improving Hypertension Control in CHina and ARGEntina With a Mobile APP-based Telecare System
NCT03206814
Intelligent Hypertension Intervention Study
NCT05526300
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In Shanghai Tenth People's Hospital, we recruit consecutive patients who meet the including criteria. And their medical and family history are obtained with standardized structured questionnaire including information about smoking and drinking and exercise habits, history of diabetes mellitus, cardio-cerebrovascular disease, renal disease and peripheral arterial disease, use of antihypertensive, lipid-regulating and hypoglycemic drugs. Their biochemical examinations of venous blood and urine were measured after an overnight fast.
For the 24-hour brachial and aortic ambulatory blood pressure monitoring of each patient, we use the Mobil-O-Graph NG apparatus (IEM, Stolberg, Germany), which is well validated and now commercially available.
All participants underwent carotid and cardiac ultrasonography by a validated ultrasound system (Mylab 30 CV machine, ESAOTE SPA, Genoa, Italy). The parameters of cardiac function and structure and the parameters of carotid arteries are assessed according to the ASE recommendation. Further, we use these parameters to estimate the damage of heart and carotid artery including left ventricular mass index (LVMI), carotid left ventricular diastolic function (LVDD), intima-media thickness (CIMT) and cross-sectional area(CCSA).
Four years later, the above measurements will be performed again and the corresponding data of events and mortality will be collected.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No intervention in this study
No intervention in this study
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* the absence of sinus rhythm during BP monitoring
* any modification in cardiovascular disease medication in the past month
* inability to provide informed consent or unwillingness/inability to adhere to study protocol
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai 10th People's Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ya-Wei Xu
Director of Department of Cardiology, Professor of Tongji University, FACC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Aissopou EK, Argyris AA, Nasothimiou EG, Konstantonis GD, Tampakis K, Tentolouris N, Papathanassiou M, Theodossiadis PG, Papaioannou TG, Stehouwer CD, Sfikakis PP, Protogerou AD. Ambulatory Aortic Stiffness Is Associated With Narrow Retinal Arteriolar Caliber in Hypertensives: The SAFAR Study. Am J Hypertens. 2016 May;29(5):626-33. doi: 10.1093/ajh/hpv145. Epub 2015 Aug 24.
Zhang Y, Kollias G, Argyris AA, Papaioannou TG, Tountas C, Konstantonis GD, Achimastos A, Blacher J, Safar ME, Sfikakis PP, Protogerou AD. Association of left ventricular diastolic dysfunction with 24-h aortic ambulatory blood pressure: the SAFAR study. J Hum Hypertens. 2015 Jul;29(7):442-8. doi: 10.1038/jhh.2014.101. Epub 2014 Nov 13.
Protogerou AD, Argyris AA, Papaioannou TG, Kollias GE, Konstantonis GD, Nasothimiou E, Achimastos A, Blacher J, Safar ME, Sfikakis PP. Left-ventricular hypertrophy is associated better with 24-h aortic pressure than 24-h brachial pressure in hypertensive patients: the SAFAR study. J Hypertens. 2014 Sep;32(9):1805-14. doi: 10.1097/HJH.0000000000000263.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SAFAR-CN
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.