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临床试验/NCT07453251
NCT07453251招募中不适用

Strength Tracking From Wall Tichness Over Aortic Biomechanics

IRCCS Policlinico S. Donato1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年10月25日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Strength to rupture

研究概览

简要总结

The aim of the study is to analyse the resected portion of aneurysmatic ascending aorta in order to assess its strength to rupture, standardise the various measurements performed within the lab and try to correlate these qualitative results with quantitative results (regarding aortic diameter, valve morphology and aortic wall thickness).

详细描述

The aortic wall is subjected to mechanical stresses in radial, circumferential, and longitudinal directions. The amount of these shear stresses varies with the distribution of velocity across the vessel lumen and with local vessel geometry.

Diseases affecting the thoracic aorta can be categorized into acute and chronic. Chronic aortic pathologies are chronic aortic dissections and aortic aneurysms.

Today, there are computational tools available to permit the calculation of stresses of the aortic wall.

For the above-mentioned reasons, this study becomes of extreme interest as it may be capable of further assessing the mechanical properties of the dilated aortic tissue, its' strength to rupture and stiffness, in order to provide an overview of the fragility of ascending aortic aneurysms. This parameter, associated to the diameter of the pathological aorta, may provide an additional tool regarding the clinical history of patients and insight concerning surgical indication.

Matter of factly, knowing the risk of rupture based on diameter may have strong implications on the preoperative evaluation of patients and the decision-making process.

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

  • Patients undergoing cardiac surgery for either aortic root and/or ascending aortic aneurysms; • Patients that have received, understood and signed the written informed consent for this study.

排除标准

  • Patients that have already undergone previous cardiac surgery; • Patients that present with acute aortic pathologies, such as acute aortic dissection or intramural hematoma.

结局指标

主要结局

Strength to rupture

时间窗: During laboratory testing

Define the strength to rupture of the removed aortic segments and its relation with the circumferential and longitudinal direction along the aortic axis.

次要结局

  • Evaluate aortic characteristics(From surgery to laboratory testing)

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

Alessandra Sala

Cardiac Surgeon

IRCCS Policlinico S. Donato

研究点 (1)

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