EUROAAOCA Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Incidence of adverse events at follow up
研究概览
简要总结
Anomalous aortic origin of a coronary artery (AAOCA) is a group of rare congenital heart defects with various clinical presentations. The lifetime-risk of an individual living with AAOCA is unknown, and data from multicentre registries are urgently needed to adapt current recommendations and guide optimal patient management. The European Registry for AAOCA (EURO-AAOCA) aims to assess differences with regard to AAOCA management between centres.
详细描述
EURO AAOCA study database on management for "ANOMALOUS AORTIC ORIGIN OF CORONARY ARTERIES.
This is a simple Excel database in 8 sections (see below). The patient's identification (ID) should be anonymous, and can be decided by each center; the investigators suggest to enclose Centre ID number (which is communicated by the leading center) and a sequential number or date of birth (dd/mm/yy).
If no procedure has been done for the patients , it is required to the "PERIPROCEDURAL, SURGICAL DETAILS" and "POSTPROCEDURAL" data sheets (which are outlined in RED). In the "PERIPROCEDURAL" sheet, the participants may refer either to the surgical or non surgical procedure.
Baseline and long term clinical evaluation sections must be completed for all patients.
In the database, there are lists of multiple different variables which are summarized in tables enclosed in the section, in which each item corresponds to a number.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 with a diagnosis of AAOCA (either referred to surgery or to medical follow-up )
排除标准
- •isolated high-coronary take-off (≥ 5mm above sino-tubular junction), anomalous origin of a circumflex from the right coronary artery, anomalous course with a normal origin, and association to major congenital heart disease (i.e. Tetralogy of Fallot, transposition of the great arteries, anomalous origin of a coronary from the pulmonary artery).
结局指标
主要结局
Incidence of adverse events at follow up
时间窗: 5 years
The study will assess the incidence of death and adverse events at clinical follow up either in patients who required a surgical repair or in those who did not undergo surgery because of lack of indications.
Incidence of Symptoms at diagnosis and after surgery
时间窗: 5 years
The study will assess the presence of symptoms (angina, chest pain, distress, sudden cardiac death-SCD, syncope, aborted SCD) at diagnosis, and after eventual surgical repair, to assess incidence of symptoms in patients with this anomaly and effectiveness of surgery in removing symptoms.
Incidence of postoperative adverse events
时间窗: 5 years
The study will assess the incidence of operative death and adverse events after surgery (in those who undergo surgery).
次要结局
- Incidence of any arrhythmias at Follow up(5 years)
- Rate of return to unrestricted competitive sport(5 years)
研究者
PADALINO MASSIMO
Associate Professor
University of Padova