Establishment of Local Arterial Stiffness Normal Values (Carotid and Femoral) on Healthy Volunteers Using Supersonic Shear Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- Normal Values by SSI
研究概览
简要总结
Arterial stiffness is associated with increased risk of cardiovascular events and death.
Most of existing technique need dedicated device for arterial stiffness evaluation and indirect calculation of intra arterial pressure. Supersonic Shear Imaging (SSI) is a novel non-invasive technique based on remote palpation of biological tissues that can image with very high temporal resolution (up to 10,000 images/s) and quantify the local viscoelastic properties of tissues. The investigators goal was to apply this SSI technique for arterial stiffness evaluation and local pulse wave velocity (PWV) calculation.
As a first step, the primary goal of this study is to establish normal values of local pulse wave velocity and arterial stiffness (carotid and femoral) by SSI on hundred healthy volunteers.
详细描述
Provide a more extensive description, if desired. Avoid duplication of information to be recorded elsewhere, such as eligibility criteria or outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Healthy Volunteers
- •Healthy volunteers between 18 and 70 years old of two sexes.
- •Caucasian origin
- •No tobacco or stopped for more than 5 years
- •BMI between 18 and 30 kg/m
- •Blood pressure after 5 minutes of rest < 140 and 90 mmHg.
- •Biological test (haematological biochemistry test in blood , urine test and toxicology tests are all normal) ECG, Blood pressure and Heart rhythm normal.
- •All volunteers received information on the research and signed the consent form.
- •Health system protection required
- •Inclusion criteria for patient :
- •Age between, 18 et 70 years old for the two sexes
- •Presence of two major criteria of Villefranche classification (Am J Med Genet 1998 ;77:31-7) and/or heterozygote pathogen mutation of COL3A1 gene.
- •At least 4cm long normal arterial segment (carotid or femoral) analyzed by mode B echograph.
- •All patient received information on the research and signed the consent form.
- •Health system protection required
排除标准
- •Pregnancy
- •Echograph gel allergy
- •Local Artery disease (dissection or thrombosis)
- •Arrhythmia
- •No health insurance coverage
- •Incapacity or refused to sign the consent form
- •Exclusion criteria for Healthy volunteers
- •Acute or Chronic Systemic disease (atherosclerosis)
- •Alcohol abuse or drug abuse (cocaine,cannabis,etc..)
- •Active or past tobacco
- •Hypercholesterolemia (LDLc >1.09 g/l)
- •Exclusion period according to the national record for volunteer of clinical trial.
- •Exclusion criteria for Patients
- •No intact (carotid or femoral) segment for SSI analysis
- •AT2 inhibitors or Beta blockers treatment will be notified but are not considered as exclusion criteria.
结局指标
主要结局
Normal Values by SSI
时间窗: day one
Normal Values by SSI of local PWV and arterial wall stiffness(carotid and femoral).
次要结局
- Comparison between 2 populations of values by SSI(Day one)
- repeatability of the "primary outcome measure"(Day one)
- Comparison of values between SSI and standard gold(Day one)