- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03334474
Shnaghai Shengkang Medical Center
November 3, 2017 updated by: Guoxiang Fu
The process of population aging that is occurring in developed societies represents a major challenge for the health system.
The aim of this study is to analyze factors that have an influence on early vascular aging (EVA), estimated by carotid-femoral pulse wave velocity (cf-PWV) and Cardio Ankle Vascular Index (CAVI), and to determine differences by gender in a Chinese population.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
1000
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Study population It will be the urban population attached to the Health Center of Shanghai.
Using a random sampling stratified by age groups and gender, 300 subjects will be selected in each group (150 males and 150 females), aged 35 to 85 years.
Description
Inclusion Criteria:
- • Patients aged 35 to 85 years who agree to participate in the study and do not meet any of the exclusion criteria.
Exclusion Criteria:
• Subjects who are in terminal condition, who cannot travel to the health centers to undergo the corresponding examinations, and those who do not wish to sign the informed consent.
- Subjects with a history of CVD (ischemic heart disease or stroke, peripheral arterial disease or heart failure), diagnosed renal failure in terminal stages (glomerular filtration rate below 30%), chronic inflammatory disease, or acute inflammatory process in the past three months.
- Patients treated with estrogens, testosterone, or growth hormone.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
young
18-35 years old
|
middle
35-65 years old
|
aged
65-85 years old
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardio-ankle vascular index
Time Frame: 2 years
|
This parameter will be estimated using Vasera device VS-1500.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 1, 2018
Primary Completion (Anticipated)
February 1, 2021
Study Completion (Anticipated)
May 1, 2021
Study Registration Dates
First Submitted
November 3, 2017
First Submitted That Met QC Criteria
November 3, 2017
First Posted (Actual)
November 7, 2017
Study Record Updates
Last Update Posted (Actual)
November 7, 2017
Last Update Submitted That Met QC Criteria
November 3, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- shengkang
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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