跳至主要内容
临床试验/NCT06200870
NCT06200870尚未招募不适用

Iron Deficiency as a Promoter of Intra-leaflet Haemorrhage-induced Aortic Valve Calcification

Qilu Hospital of Shandong University0 个研究点目标入组 3,000 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
3,000
主要终点
Total iron binding capacity

研究概览

简要总结

Calcific aortic valve disease (CAVD) is a highly prevalent, disabling and costly disorder with generally poor long-time outcomes once critical stenosis presents with symptoms. Elucidating viable therapeutic strategies for CAVD is pressing. Valvular interstitial cells (VICs) control the structure and function of aortic valve. Intra-leaflet haemorrhage (IH), commonly occurring in histologically stenotic aortic valves, while, in 2019, researchers pointed that iron deposits also presented obviously healthy valves. In line with this, later exploration from vitro showed that iron stimulation alone could not promote VICs calcification. Iron deficiency (ID) is a frequent co-morbidity in multiple chronic cardiovascular diseases such as CAVD; up to 50% of patients with severe aortic stenosis present ID. Data from a small clinical study in patients undergoing TAVI showed those in ID status appeared much higher mean transaortic gradient; whereas no studies have assessed the correlation between ID and aortic valve remodelling and dysfunction progress itself. Here, the investigators aim to investigate for a tentative correlation between ID and human aortic valve remodeling and dysfunction.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • if performed with both color doppler echocardiography and anemia profile on admission as part of routine checkup.

排除标准

  • if younger than the age of 18;
  • if no anemia profile or doppler echocardiography was measured;
  • if anemia profile or doppler echocardiography was analyzed in external laboratories;
  • if had a history of rheumatic heart disease, infective endocarditis or any other congenital disorders that may implicate aortic valve structures, such as bicuspid aortic valve morphology, Marfan syndrome, and so on.

结局指标

主要结局

Total iron binding capacity

时间窗: within 24 hours of admission

Total iron binding capacity will be reported in μmol/L.

Serum transferrin receptor

时间窗: within 24 hours of admission

Plasma levels of serum transferrin receptor will be reported in g/L.

Unsaturated iron-binding capacity

时间窗: within 24 hours of admission

Serum iron and total iron binding capacity will be combined to report unsaturated iron-binding capacity in μmol/L.

Soluble transferrin index

时间窗: within 24 hours of admission

Serum iron and serum transferrin will be combined to report soluble transferrin index.

Serum transferrin

时间窗: within 24 hours of admission

Plasma levels of serum transferrin will be reported in g/L.

Transferrin saturation

时间窗: within 24 hours of admission

Serum iron and total iron binding capacity will be combined to report transferrin saturation in %.

Serum iron

时间窗: within 24 hours of admission

Plasma levels of serum iron will be reported in μmol/L.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chuanbao Li

Prof.

Qilu Hospital of Shandong University

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