New Patient-specific Functional Assessment of the Anomalous Aortic Origin of Coronary Arteries.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Identification of myocardial ischemia on simulation model
研究概览
简要总结
Anomalous Aortic Origin of the Coronary Arteries (AAOCA) is a rare congenital disease that may cause sudden death in young subjects. Frequently the first and only presentation is with an acute event (such as myocardial infarction or sudden cardiac deaths) during physical effort. Not only symptoms are often absent, but also provocative tests fail to induce ischemia or related signs, showing in most patients negative results. For these limitations, the decision to undergo corrective surgery is based on the morphologic characteristics without the support of a functional evaluation. The study focused on developing a personalized ischemic risk assessment with the aid of fluid dynamic simulations. The simulation system integrate clinical data from different diagnostic sources and integrate them with coronary blood flow evaluation at rest and during simulated physical effort.
详细描述
Anomalous Aortic Origin of Coronary Arteries (AAOCA) is a congenital condition where one or more coronary vessels originate from an ectopic site within the aorta, such as the opposite or wrong sinus of Valsalva. Its prevalence in the general population, has been estimated between 0.03% and 0.23% depending on the variant evaluated. The anomalous left or right coronary artery, besides its origin, may take 5 different general courses: interarterial, prepulmonic, subpulmonic, retroaortic or retrocardiac. Each of these forms may be subject to cause myocardial ischemia and subsequent sudden death during physical and sport activity.
In most cases, the disease is silent and does not show any symptoms before the sudden cardiac death event (SCD). Only a few AAOCA subjects report symptoms before SCD that usually occurs unexpectedly after a moderate or intense physical activity. It is extremely hard to study the causing factors in a clinical environment due to the stochastic nature of the myocardial ischemic event and the inability to reproduce the exact effort conditions.
Even when a complete assessment is performed, there is no clinical exam that can reproduce sustained exercise conditions responsible for triggering ischemia and SCD. Even if such an exam would exist and provide adequate results, the risk of SCD exceeds the benefits of having a correct diagnosis.
To overcome all the current diagnostic limitations the ideal diagnostic test has to investigate coronary blood supply, myocardial oxygen demand in relation to the physical activity (intensity and duration) required for triggering an ischemic event, without putting the subjects at risk. To date the only possible way to reproduce such conditions is a subject-specific virtual simulation of aortic root and coronary artery integrated with coronary blood flow simulation able to mimic pressure, flow, and oxygen demand characteristics similar to those of intense exercise, in relation to changes that anomalous coronary undergoes under such conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of AAOCA of any age will undergo fluid dynamic simulation
- •Patients with age > 14 with diagnosis of AAOCA will undergo to invasive coronary flow measurements
- •Informed consent
排除标准
- •A presence of major associated congenital heart anomalies
- •Contraindication to the execution of the diagnostic examination requested such as age < 14 years for invasive coronary flow measurements
研究组 & 干预措施
Anomalous coronary blood flow
Subjects suspected to have AAOCA will be submitted to angiographic coronary CT imaging to confirm the diagnosis. If the diagnosis of AAOCA will be confirmed, subjects will undergo to invasive coronary blood flow evaluation (intervention).
干预措施: Invasive coronary blood flow assessment and simulations and fluid dynamic patient specific simulation (Diagnostic Test)
结局指标
主要结局
Identification of myocardial ischemia on simulation model
时间窗: 3 years
Assess myocardial ischemia in the patient's specific model during simulated effort correlating coronary artery blood supply to myocardial oxygen demand.
次要结局
- Invasive coronary flow distribution assessment(During clinical diagnostic evaluation, average 3 months after)
- In vitro effort fluid dynamic simulation(3 years)
- Integration of different coronary artery imaging modality(During clinical diagnostic evaluation, average 6 months)
- Computational fluid dynamic simulation(3 years)
研究者
Mauro Lo Rito
Pediatric Cardiac Surgeon and Research Associate
IRCCS Policlinico S. Donato