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临床试验/NCT06497478
NCT06497478已完成不适用

Evolutionary Aspects of Polydistrict Atherosclerosis (EAP). Analysis and Correlation of Functional, Biomolecular and Genetic Factors.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2014年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
320
试验地点
1
主要终点
Assessment evolutionary aspects of atherosclerosis

研究概览

简要总结

Atherosclerosis is a systemic, multifocal disease that represents the leading cause of death in Western countries. The risk factors contributing to its distribution, extent and progression in different organs (i.e., the heart, brain or limbs) and different segments (large and small vessels) are not identical. The present study analyses data the evolutionary aspects of polydistrict atherosclerosis by analysing the possible role of morphological factors, biomolecular and genetic in the progression of atherosclerotic lesions and the development of major and/or minor acute cardiovascular events.

For this purpose, will be recalled to follow-up all 320 patients already enrolled in the previous protocol of Research in the period between 1 March 2014 and 28 February 2015 at the Department of Internal Medicine, Catholic University of Rome.

The subjects will undergo a new clinical evaluation, with particular interest to the onset of major cardiovascular events (myocardial infarction, stroke, death for all causes) and major adverse events to the lower limbs (critical ischemia of the lower limbs requiring revascularization or amputation) in the follow-up period, and a ultrasonographic examination of carotid arteries and arteries of lower limb districts at the Service of Angiology, Catholic University of Rome.

The study employed a new semiquantitative ultrasonographic score (ultrasonographic lower limb atherosclerosis (ULLA) score), that enables a complete evaluation of the entire lower limb atherosclerotic burden and has already been shown to be associated with major cardiovascular risk factors.

Therefore, the aims of this study are:

  • to assess the association between functional, morphological, biomolecular and genetic factors of atherosclerotic disease and the risk of major cardiovascular events (MACE) and major adverse events to the lower limbs (MALE);
  • to analyse the morphological progression of atherosclerotic disease in its different localizations and the possible determining factors in such progression with a 10-year follow-up ultrasound study.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Follow-up of n.320 subjects previously enrolled in the period between 1 March 2014 and 28 February 2015 in the previous Research Protocol at the Department of Internal Medicine, Catholic University of Rome.

排除标准

  • Acute diseases;
  • Age < 18 years;
  • Inclusion in another clinical trial;
  • Impossibility of follow-up (homeless, residence abroad)

结局指标

主要结局

Assessment evolutionary aspects of atherosclerosis

时间窗: 6 months

The association between functional, morphological, biomolecular and genetic factors of atherosclerotic disease and the risk of major cardiovascular events (MACE) and major adverse events to the lower limbs (MALE)

次要结局

  • Morphological progression of atherosclerosis and factors involved(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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