Chinese Arteriosclerosis Series Evaluation-She Minority Study (CASE-SMS)
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|ClinicalTrials.gov Identifier: NCT02933957|
Recruitment Status : Recruiting
First Posted : October 14, 2016
Last Update Posted : October 14, 2016
|Condition or disease|
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.
- 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 Type :||Observational|
|Estimated Enrollment :||300 participants|
|Observational Model:||Ecologic or Community|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||October 2017|
- value of brachial ankle pulse wave velocity [ Time Frame: one and a half years ]
- 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 ]Carotid ultrasound will be used to measure the thickness of carotid intimate-media.
- Presence of Carotid Plaque [ Time Frame: one and a half years ]Carotid ultrasound will be used to measure the presence of carotid plaque according to Mannheim Consensus
- Number of peripheral arteriosclerosis occlusion measured by ankle brachial index [ Time Frame: one and a half years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933957
|Contact: Hong yu Wang, Doctorfirstname.lastname@example.org|
|Peking University Shougang Hospital||Recruiting|
|Beijing, Beijing, China, 100144|
|Contact: Huan Liu, Master +861057830226 email@example.com|