跳至主要内容
临床试验/NCT06786754
NCT06786754Enrolling By Invitation不适用

FIBROBLASTS AND THORACIC AORTIC ANEURYSMS: IN VITRO CHARACTERIZATION IN PATIENTS WITH MARFAN SYNDROME AND GENETIC AORTIC DISEASES

IRCCS Policlinico S. Donato2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年6月17日最近更新:
适应症

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

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

发起方
IRCCS Policlinico S. Donato
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alessandro Pini

Principal Investigator

IRCCS Policlinico S. Donato

研究点 (2)

Loading locations...

相似试验