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临床试验/NCT04809506
NCT04809506招募中不适用

Bio-collection for the Discovery of New Biomarkers for the Prediction of Cardiovascular Events

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2021年2月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
1,500
试验地点
1
主要终点
measurement of the candidate biomarker

研究概览

简要总结

The main goal of this project is to constitute a collection of biological samples, obtained through the clinical activity of the Centre for Screening and Prevention of Atherosclerosis at Toulouse University Hospital, managing patients in primary or secondary prevention for cardiovascular (CV) diseases. The main objective is to validate new biomarkers with prognostic value regarding the onset of future CV events. Besides, the biological collection will enable patho-physiological studies on atherosclerosis related diseases.

详细描述

Cardiovascular (CV) diseases, particularly those secondary to atherosclerosis, are a leading cause of morbidity and mortality in modern societies. Classical CV risk factors, including age and gender, family history, tobacco smoking, hypertension, diabetes, dyslipidemia and obesity cannot predict more than 50% of future CV events. Use of specific scores (like the SCORE chart) does not much contribute to the precise evaluation of patients classified at moderate risk. Thus, more research is needed: 1) to study patho-physiological mechanisms of the atherothrombotic process in order to identify new pharmacological targets and, 2) to validate new biomarkers with a strong predictive value regarding the onset of hard CV clinical events. Moreover, genetic polymorphisms underlie an individual's susceptibility to develop atherosclerotic diseases. Identification of those gene variants might help to define a personalized approach for the treatment of CV diseases. Patients consulting the Centre for Screening and Prevention of Atherosclerosis (CDPA) are submitted to a personal face-to-face interview addressing their life style, nutritional and smoking habits, and their physical activity practice. Clinical examination includes ECG, stress test, ankle-arm systolic index, ultrasonography of arteries (carotid, aorta, lower limb) and determination of a coronary calcification score. Blood samples are taken up for chemistry measurements including lipoproteins (triglycerides, LDL-C, HDL-C, Lp(a)). For the specific purpose of the biological collection, two supplementary blood tubes will be collected (2 x 7 ml); serum, plasma and genomic DNA will be prepared. Patients will be followed up yearly for those on secondary prevention and every 2nd year on primary prevention. Identical investigation will be carried out at every visit. Recruitment period will spread over 5 years and follow-up will be pursued up to 8 years.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults over 18 yrs;
  • consulting the Centre for Screening and Prevention of Atherosclerosis (CDPA) for management of their cardiovascular risk factors;
  • patients on primary prevention, free of personal history of coronary artery disease, stroke or lower limb arteriopathy, or patients on secondary prevention having presented one of the above mentioned diseases;
  • patients affiliated to a health insurance system;
  • patients having given their written informed consent for a participation to the study and for possible genetic analysis of their personal traits.

排除标准

  • Patients under the age of 18;
  • patients being under legal protection

研究组 & 干预措施

Patient consulting the Centre for Screening and Prevention of Atherosclerosis

2 additional blood samples (2 x 7ml) at every visit

干预措施: additional blood samples (Biological)

结局指标

主要结局

measurement of the candidate biomarker

时间窗: during the intervention/procedure/surgery

measurement, at baseline of the candidate biomarker, with respect to the onset, during follow-up, of a cardiovascular event: either coronary events or cerebrovascular stroke or lower limb arteriopathy.

次要结局

  • evolution of clinical and biological parameters involved in atherothrombosis(during the intervention/procedure/surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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