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临床试验/NCT05065996
NCT05065996已完成不适用

Prediction of Aortic Dilation and Rupture in Different Predisposing Pathologies A Prospective Clinical Study

Kuopio University Hospital1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
170
试验地点
1
主要终点
Association of FD to aortic dilatation rate

研究概览

简要总结

Aortic aneurysm is a very common incidental finding in the diagnostic imaging of the chest. It is especially common in middle aged men (up to 40 %). It is called as a silent killer, since it can lead to aortic dissection and rupture without pre-existing symptoms. Mortality of rupture can be up to 50 %. This is why it causes extensive human uncertainty and fear. Currently, there are no methods to identify the high risk patients. That leads to a practice where all patients are followed with repeated aortic imaging using expensive methods such as magnetic resonance imaging (MRI) and computed tomography.

There is data, that modern 4D flow MRI parameters well describe the intra-aortic flow conditions. This prospective clinical trial explore the value of 4D flow MRI parameters in the prediction of aortic dilatation and rupture. The trial consists of three subtrials in whitch the 4D flow MRI parameters are tested in clinical practice.

详细描述

  1. Purpose of the study The purpose of this study is to explore prognostic parameters for aortic dilation. More specifically it is to identify prognostic imaging parameters which could be used to identify patients at high risk for rapid aortic dilation and should be intensively followed by imaging methods.

  2. Subtrials

  3. Clinical study 1 The aim of the first phase of the study targets to identify 4D MRI flow parameters which are characteristic to dilated aorta and might be used to evaluate future prognosis in patients with aortic dilatation or predisposing factors.

  4. Clinical study 2 The second phase of the study aims to use identified flow parameters in clinical imaging follow up to find out which parameters predict aortic dilation in real life and thus could be used to select patients for more intensive imaging in future.

  5. Study 3 - Molecular pathology, histology and genetics of aorta The aim of this part of the study is to find out differences in molecular biology, histology, elasticity and genetics of the aorta in patients having predisposing factors for aortic dilation. Particularly, cellular factors influencing the formation of connective tissue and vascular smooth muscle layer will be studied.

  6. Methods

  7. Patient population All patients and healthy volunteers will give their written informed consent for the study. The Ethical Committee of Northern Savo hospital district has given approval for the trial.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aortic dilatation
  • scheduled for imaging follow up in Kuopio University Hospital
  • written informed concent

排除标准

  • lack of co-operation
  • contraindications to MRI

结局指标

主要结局

Association of FD to aortic dilatation rate

时间窗: 5 years

4D flow MRI flow displacement value in correlation to aortic diameter in different time points

Association of WSS to aortic dilatation rate

时间窗: 5 years

4D flow MRI wall shear stress value in correlation to aortic diameter in different time points

次要结局

未报告次要终点

研究者

发起方
Kuopio University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marja Hedman

Professor

Kuopio University Hospital

研究点 (1)

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