FIBROBLASTS AND THORACIC AORTIC ANEURYSMS: IN VITRO CHARACTERIZATION IN PATIENTS WITH MARFAN SYNDROME AND GENETIC AORTIC DISEASES
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Fibroblasts phenotype: cell morphology and migration
研究概览
简要总结
The aim of the present study is to characterise the phenotype of fibroblasts and to classify different mechanisms involved in the onset and progression of TAAD in syndromic and non-syndromic subjects in order to evaluate potential markers related to TAAD.
详细描述
The aim of the study is to analyse cutaneous fibroblast properties in patients with thoracic aortic aneurysms (both syndromic and non-syndromic) to identify differences in molecular mechanisms in collagen turnover pathways compared to healthy controls in the general population.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(general for the study):
- •signed informed consent; subjects aged 18 years and above.
- •Inclusion Criteria (Case):
- •subjects with Marfan syndrome and thoracic aortic aneurysms (in clinical follow-up or with cardiac surgery program); subjects with non-syndromic thoracic aortic aneurysms (in clinical follow-up or with cardiac surgery program);
- •Inclusion Criteria (healthy controls):
- •absence of any aortic/thoracic disease;
排除标准
- •(all groups):
- •Presence of any confounding cardiovascular risk factor (hypertension, dyslipidaemia, diabetes, smoking habits) or previous cardiovascular disease
- •Corticosteroid or Steroids or Fluorochinolones treatment within six months before enrollment Subjects on chronic immunosuppressive therapies such as oral steroids, but also on chronic topical steroids in the area of investigation;
- •A history of keloid formation (data found in anamnesis and medical records);
- •Anaesthetic drug allergy (data found in anamnesis and medical records).
结局指标
主要结局
Fibroblasts phenotype: cell morphology and migration
时间窗: 12 months
cell morphology: phase-contrast microscopy
次要结局
- Levels of metalloproteinases involved in ECM degradation(24 months)
- Expression of genes and proteins involved in collagen turnover and extracellular matrix remodeling pathways(16 months)
研究者
Alessandro Pini
Principal Investigator
IRCCS Policlinico S. Donato
