Predictors of Aortic Root Dilatation in Tetralogy of Fallot Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 77
- 主要终点
- Aortic root diameters
研究概览
简要总结
- To predict vulnerable patients for aortic root dilatation in TOF patients using CT as a reliable imaging modality, thus aiding early intervention, and identifying those who will require strict follow-up.
- To assess the prevalence of TOF patients who developed aortic root dilatation, and those who were complicated with dissection, AR, and aneurysm, through collecting data from a large center (Aswan Heart Centre).
- To investigate the relationship between age at repair and the diameter of aortic root.
详细描述
Tetralogy of Fallot (TOF) occurs in approximately 3 to 5 of every 10,000 live births and is the most common cyanotic congenital heart defect and it exhibits four main features. These features are pulmonary stenosis, right ventricular hypertrophy, overriding aorta and ventricular septal defect. Moreover, since the survival of patients with congenital heart diseases has improved significantly in recent decades, long-term complications should be monitored cautiously. One of these complications is aortic root dilatation, attributed to increased and altered flow through the overriding aorta and an uneven sharing of conotruncal tissue between the aorta and pulmonary artery, particularly in patients who have not undergone early repair.
Despite the concern that TOF patients may harbor aortopathy that can lead to aortic regurgitation, aortic aneurysms, and, potentially, aortic dissection, the scope of the problem remains uncertain. Prevalence estimates of aortic root dilatation have ranged from 15% to 87% with the use of various criteria. Moderate to severe aortic regurgitation (AR) has also been reported in up to 12.5% of adults with TOF and dilated aortic roots. The incidence of aortic dissection and surgical intervention remains unknown. Moreover, features associated with aortic dilatation are not fully understood. Therefore, correlating and predicting vulnerable patients and identifying possible risk factors for aortic root dilatation in TOF patients, will enable more cautious follow-up and earlier intervention, thus decreasing possible morbidity and mortality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients with TOF who either underwent or have not yet had surgical correction.
- •All patients with Fallot-type DORV.
- •Patients should have survived until discharge and have at least one echocardiography and CT with full data related to one or more anatomic subcomponents of the aortic root, either before surgery or during follow-up, regardless of specific duration post repair.
排除标准
- •Patients who have contraindication for conducting cardiac CT scan. For instance, dye sensitivity, pregnancy, CKD, in addition to patients who have factors that interfere with CT image quality as metallic objects within the chest (e.g. Pacemaker).
结局指标
主要结局
Aortic root diameters
时间窗: Throughout the study duration, about 1 year
: Aortic root diameters at four levels: 1. aortic annulus (AA) 2. sinus of Valsalva (SoV) 3. sinotubular junction (STJ) 4. ascending aorta (AAo). AA will be measured as the inter-commissural distance in the aortic valve, SoV will be measured at the level of maximal diameter on the axial image, STJ will be measured at the level of transitional zone from STJ to AAo, and AAo will be measured at the level of the main pulmonary artery bifurcation. Aortic cross-sectional area will be calculated by π×(diameter/2)2 The largest diameters of each aortic structure as measured based on the chest CT will be re-calculated as z-scores. In our study, "significant dilatation of the aortic structures" is defined as 95% confidence interval (z-score≥2) in diameter of each aortic structures. Echocardiography will be performed to check other cardiac deformities, including AR.
次要结局
- Aortic valve repair or surgical or transcatheter aortic valve replacement(Throughout the study duration, about 1 year)
- Severity of AR at latest follow-up or before the earliest aortic valve or root intervention.(Throughout the study duration, about 1 year)
研究者
Abdelrahman Gamal Ahmed Ramadan
Principle investigator
Assiut University