Genetic Aortic Diseases and Cardiovascular Complications. An Observational Survey of Risk Factors.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Journey to diagnosis
研究概览
简要总结
The aim of this observational study is to define the behavioural and cardiovascular risk factor profiles of patients with genetic aortopathies. The main questions it aims to answer are:
- How do the interconnections between lifestyle, stress, psychological condition, perception of illness, and state of health influence each other in this population?
- Beyond traditional risk factors, additional emerging factors should be considered, including pregnancy-related complications, sedentary lifestyle, early menopause and depression. The interplay between eating disorders, lifestyle factors and autoimmune or inflammatory bowel diseases remains poorly understood.
详细描述
Thoracic aortic aneurysms (TAA) present peculiar symptoms as well as high mortality due to complications related to dilatation and dissection of the ascending aorta and great arteries. The presence or absence of extra-aortic features determines whether TAADs are syndromic, associated with diseases affecting other systems and organs, or non-syndromic, with manifestations limited to the aorta. Life expectancy of patients withTAA has improved markedly in the last decades, but still remains lower than that of the general population.
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
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed onformed consent
- •Ability to speak, read and write in Italian
排除标准
- 未提供
研究组 & 干预措施
TAA
subjects with TAA aged between 14 and 60 years
干预措施: Journey to diagnosis (Other)
TAA
subjects with TAA aged between 14 and 60 years
干预措施: Quality of life, functional health and well-being (Other)
TAA
subjects with TAA aged between 14 and 60 years
干预措施: Awareness and self-esteem, acceptance of the condition (Other)
TAA
subjects with TAA aged between 14 and 60 years
干预措施: psychological and physical well-being (Other)
结局指标
主要结局
Journey to diagnosis
时间窗: 15 months
The mean, median, standard deviation and interquartile range will be used for continuous variables, whereas frequency and percentage will be applied for nominal and categorical variables. The Shapiro-Wilks test will be used to assess the Gaussian distributions.
Quality of life, functional health and well-being
时间窗: 15 months
The mean, median, standard deviation and interquartile range will be used for continuous variables, whereas frequency and percentage will be applied for nominal and categorical variables. The Shapiro-Wilks test will be used to assess the Gaussian distributions.
Awareness and self-esteem, acceptance of the condition
时间窗: 15 months
The mean, median, standard deviation and interquartile range will be used for continuous variables, whereas frequency and percentage will be applied for nominal and categorical variables. The Shapiro-Wilks test will be used to assess the Gaussian distributions.
psychological and physical well-being
时间窗: 15 months
The mean, median, standard deviation and interquartile range will be used for continuous variables, whereas frequency and percentage will be applied for nominal and categorical variables. The Shapiro-Wilks test will be used to assess the Gaussian distributions.
次要结局
未报告次要终点
研究者
Alessandro Pini
MD
IRCCS Policlinico S. Donato