Vascular DiseaseCASE-SMSNCT02933957
Chinese Arteriosclerosis Series Evaluation-She Minority Study
An observational study of Vascular Disease, run by Peking University Shougang Hospital at 1 site in China.
Trial summary
Traditionally, people have always been focusing on vascular injuries by angiography. Recent years, the investigators have further known that the pathological foundation of various cardiovascular complications not only lies in the vascular lumen, but also vessel wall. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Disease
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Oct 2017
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants are natural population, from She Minority in Fujian province
Who may be able to join
- Voluntary participation
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100144
Huan Liu, Master, +861057830226, sgliuhuan@163.com
About this study
Traditionally, people have always been focusing on vascular injuries by angiography. Recent years, the investigators have further known that the pathological foundation of various cardiovascular complications not only lies in the vascular lumen, but also vessel wall. Therefore, now it is possible to detect and prevent vascular disease early. There are many influencing factors on functional and structural damages of vessels, including genetic and environmental factors. The investigators have done many researches on populations of the Han nationality, which has the largest population in China. Thus, the investigators further wonder whether the function and structure of vessel differ in the She Minority of a remote southern region in China. The investigators will enroll 150 subjects of two ethnic groups respectively in the local population， namely She Minority and Han nationality. All subjects enrolled into the study will complete a questionnaire survey of the general situation and conduct vascular related examinations, including evaluation of arterial stiffness, arterial elasticity indexes, subclinical carotid atherosclerosis and biomarkers. The investigators will analysis vascular differences between the two populations and provide a theoretical basis for the specific strategies of prevention and treatment.
Read the detailed description
Population Subjects volunteered to participate the study will be all enrolled into the study. The study is designed to enroll subjects from two ethnic groups in the local population, namely She Minority and Han nationality. All participants will be asked to sign a written informed consent and the study has been approved by the hospital.
Methods
- Questionnaire The questionnaire survey included family history, disease history (including coronary artery disease, cerebrovascular disease, hypertension, diabetes mellitus, peripheral artery disease), medication history (including cardiovascular drugs, hypertension drugs, diabetes drugs, lipid-lowering drugs), physical activity, smoking condition, drinking status, dietary and life habits etc.
- Arterial stiffness by vascular function apparatus Arterial stiffness is assessed by brachial-ankle pulse wave velocity (ba-PWV) using an automatic vascular function apparatus. Subjects lie on the detection bed resting about 10 minutes and the apparatus record the value of ba-PWV automatically.
- Peripheral artery detection by vascular function apparatus Ankle-brachial index (ABI) is used as an evaluation index of peripheral artery and can be measured by an automatic vascular function apparatus. During the detection of ABI, the blood pressure of the four limbs will be measured simultaneously.
- Arterial elasticity indexes by carotid ultrasound apparatus A Doppler ultrasound apparatus with a built-in software named quality arterial stiffness (QAS) will be used to measure arterial elasticity indexes, including stiffness coefficient β, pressure strain elastic coefficient, arterial compliance etc.
- Subclinical carotid atherosclerosis by carotid ultrasound apparatus Assessment indexes of subclinical atherosclerosis including carotid intima-media thickness (IMT), carotid plaque, carotid internal diameter， carotid blood flow peak velocity, diastolic peak velocity of carotid artery, average velocity, resistance index (RI) and pulsation index (PI) will be measured by Doppler ultrasound apparatus. A more qualified detection of IMT will be also complete by a Doppler ultrasound apparatus with a built-in software named quality intima-media thickness (QIMT).
- Vascular endothelial function detection Vascular endothelial function will be assessed by a noninvasive method of brachial ultrasound, named flow mediated dilation (FMD). Subjects lie on the detection bed resting 10 minutes and the operator will detect two times of the brachial artery diameter before and after hyperemia.
- Biomarkers Biomarkers including fasting plasma glucose, plasma lipids (including total cholesterol, triglyceride, low density lipoprotein cholesterol, high density lipoprotein cholesterol), blood uric acid, blood urea nitrogen, creatinine, high sensitive C reactive protein, homocysteine lipoprotein a, Apolipoprotein A1, Apolipoprotein B, glycosylated hemoglobin, insulin, C-peptide etc.
Statistical analysis The investigators will take the double input and check all data. Statistical Product and Service Solutions (SPSS Version 20.0 ) will be the software of analyzing.
- Conditions
- Vascular Disease
- Keywords
- Vascular Evaluation, influencing factor, She Minority population
- Medical subject headings
- Vascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
value of brachial ankle pulse wave velocity
Measured: one and a half years
Secondary outcomes (5)
Percentage of flow mediated dilation
Measured: one and a half years
Value of arterial elasticity including stiffness coefficient β, pressure strain elastic coefficient, arterial compliance
Measured: one and a half years
Thickness of carotid intima-media by carotid ultrasound
Carotid ultrasound will be used to measure the thickness of carotid intimate-media.
Measured: one and a half years
Presence of Carotid Plaque
Carotid ultrasound will be used to measure the presence of carotid plaque according to Mannheim Consensus
Measured: one and a half years
Number of peripheral arteriosclerosis occlusion measured by ankle brachial index
Measured: one and a half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startJan 2015
- Primary completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseaseStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Shougang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- MinDong Hospital of Ningde City
- Responsible party
- Principal investigator, Hongyu Wang, Peking University Shougang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933957
- Sponsor's protocol ID
- PUShougangH
- Acronym
- CASE-SMS
- Status last verified
- Oct 2016
- First submitted
- 8 Oct 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Arteriosclerosis Series Evaluation-She Minority Study
- ClinicalTrials.gov ID
- NCT02933957
- Acronym / sponsor ID
- CASE-SMS / PUShougangH
- Conditions
- Vascular Disease
- Keywords
- Vascular Evaluation, influencing factor, She Minority population
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University Shougang HospitalUniversity, hospital or other
- Collaborators
- MinDong Hospital of Ningde City
- Study start
- Jan 2015
- Primary completion
- Oct 2017 (estimated)
- First posted
- 14 Oct 2016 (estimated)
- 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.
Traditionally, people have always been focusing on vascular injuries by angiography. Recent years, the investigators have further known that the pathological foundation of various cardiovascular complications not only lies in the vascular lumen, but also vessel wall. Therefore, now it is possible to detect and prevent vascular disease early. There are many influencing factors on functional and structural damages of vessels, including genetic and environmental factors. The investigators have done many researches on populations of the Han nationality, which has the largest population in China. Thus, the investigators further wonder whether the function and structure of vessel differ in the She Minority of a remote southern region in China. The investigators will enroll 150 subjects of two ethnic groups respectively in the local population， namely She Minority and Han nationality. All subjects enrolled into the study will complete a questionnaire survey of the general situation and conduct vascular related examinations, including evaluation of arterial stiffness, arterial elasticity indexes, subclinical carotid atherosclerosis and biomarkers. The investigators will analysis vascular differences between the two populations and provide a theoretical basis for the specific strategies of prevention and treatment.
Detailed description
Population Subjects volunteered to participate the study will be all enrolled into the study. The study is designed to enroll subjects from two ethnic groups in the local population, namely She Minority and Han nationality. All participants will be asked to sign a written informed consent and the study has been approved by the hospital.
Methods
- Questionnaire The questionnaire survey included family history, disease history (including coronary artery disease, cerebrovascular disease, hypertension, diabetes mellitus, peripheral artery disease), medication history (including cardiovascular drugs, hypertension drugs, diabetes drugs, lipid-lowering drugs), physical activity, smoking condition, drinking status, dietary and life habits etc.
- Arterial stiffness by vascular function apparatus Arterial stiffness is assessed by brachial-ankle pulse wave velocity (ba-PWV) using an automatic vascular function apparatus. Subjects lie on the detection bed resting about 10 minutes and the apparatus record the value of ba-PWV automatically.
- Peripheral artery detection by vascular function apparatus Ankle-brachial index (ABI) is used as an evaluation index of peripheral artery and can be measured by an automatic vascular function apparatus. During the detection of ABI, the blood pressure of the four limbs will be measured simultaneously.
- Arterial elasticity indexes by carotid ultrasound apparatus A Doppler ultrasound apparatus with a built-in software named quality arterial stiffness (QAS) will be used to measure arterial elasticity indexes, including stiffness coefficient β, pressure strain elastic coefficient, arterial compliance etc.
- Subclinical carotid atherosclerosis by carotid ultrasound apparatus Assessment indexes of subclinical atherosclerosis including carotid intima-media thickness (IMT), carotid plaque, carotid internal diameter， carotid blood flow peak velocity, diastolic peak velocity of carotid artery, average velocity, resistance index (RI) and pulsation index (PI) will be measured by Doppler ultrasound apparatus. A more qualified detection of IMT will be also complete by a Doppler ultrasound apparatus with a built-in software named quality intima-media thickness (QIMT).
- Vascular endothelial function detection Vascular endothelial function will be assessed by a noninvasive method of brachial ultrasound, named flow mediated dilation (FMD). Subjects lie on the detection bed resting 10 minutes and the operator will detect two times of the brachial artery diameter before and after hyperemia.
- Biomarkers Biomarkers including fasting plasma glucose, plasma lipids (including total cholesterol, triglyceride, low density lipoprotein cholesterol, high density lipoprotein cholesterol), blood uric acid, blood urea nitrogen, creatinine, high sensitive C reactive protein, homocysteine lipoprotein a, Apolipoprotein A1, Apolipoprotein B, glycosylated hemoglobin, insulin, C-peptide etc.
Statistical analysis The investigators will take the double input and check all data. Statistical Product and Service Solutions (SPSS Version 20.0 ) will be the software of analyzing.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are natural population, from She Minority in Fujian province
Key inclusion criteria (1 listed)
- Voluntary participation
Key exclusion criteria (1 listed)
- None
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
value of brachial ankle pulse wave velocity
Time frame: one and a half years
5 secondary outcomes
Percentage of flow mediated dilation
Time frame: one and a half years
Value of arterial elasticity including stiffness coefficient β, pressure strain elastic coefficient, arterial compliance
Time frame: one and a half years
Thickness of carotid intima-media by carotid ultrasound
Time frame: one and a half years
Presence of Carotid Plaque
Time frame: one and a half years
Number of peripheral arteriosclerosis occlusion measured by ankle brachial index
Time frame: one and a half years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Disease, run by Peking University Shougang Hospital at 1 site 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 1 inclusion and 1 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 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Hong yu Wang, Doctor (+8610-57830226, hongyuwang@188.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
value of brachial ankle pulse wave velocity (time frame: one and a half years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2016.