NCT05692063招募中不适用
Anomalous Aortic Origin of Coronary Artery: From Pathophysiology to Risk Stratification Through a Patient Specific Computational Simulation Model
IRCCS Policlinico S. Donato1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2019年6月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- ischemia, angina event, sudden cardiac death
研究概览
简要总结
This project has several objectives ranging from clinical data analysis to computational simulations as listed below:
A) Clinical objectives:
- Retrospective review of all patients with AAOCA treated surgically and followed medically at the IRCCS Policlinico San Donato aiming to identify risk factors for ischemia or sudden cardiac deaths.
- Prospective follow-up of all enrolled patients, treated and followed, in adjunct to all the new patients referred aiming to follow across the years any potential rare adverse event (ischemia, angina event, sudden cardiac death).
B) Experimental objectives:
- Retrieve morphological measurements from CT or MRI (de-identified) of the aortic root and the coronary vessels following the previous work of our group.
- Construct a parametric model of the aortic root defined by population-based morphologic parameters to describe both healthy/diseased population.
- Run solid mechanics simulation mimicking the movement of the aortic root in order to test configurations at more risk.
- Reconstruct 3D surfaces representing the coronary vasculature from imaging for automatically perform the parameter estimation and run computational fluid dynamics simulations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients (adults and pediatrics) who have been diagnosed with an anomalous aortic origin of any of the coronary arteries (AAOCA) without any other congenital heart disease and diagnosed/referred or followed at the IRCCS Policlinico San Donato.
排除标准
- •Patients with other major congenital heart disease with associated coronary artery origin anomalies will be excluded.
- •Patients with anomalous origin of the coronary artery from the pulmonary artery (ALCAPA or ARCAPA) will be excluded.
- •Patients women who are pregnant.
结局指标
主要结局
ischemia, angina event, sudden cardiac death
时间窗: 10 years
2. Creation of a prospective registry in which will be enrolled all patients already treated and followed in adjunct to all the new patients referred aiming to follow across the years any potential rare adverse event
次要结局
- risk factors for ischemia or sudden cardiac deaths(10 years)
研究者
Mauro Lo Rito
Principal Investigator
IRCCS Policlinico S. Donato
研究点 (1)
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