Prognosis and Integrative Assessment of Aortic Coarctation Patients in CHINA
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in left ventricular mass
研究概览
简要总结
This is a systemic research of Chinese aortic coarctation patients, aiming to determine risk factors and serial biomarkers of aortic coarctation in prognosis.
详细描述
The goal is to determine how much the left ventricle remodeling pre-operation and how it changes in the following-up duration after surgery, so does in the blood pressure and heart function. Risk factors associated with complications and prognosis are investigated and analyzed. Identification of novel biomarkers is needed to help predicting the prognosis, such as the left ventricle anti-remodeling, heart function and blood pressure improvement, as well as the exercise tolerance post-operation. The findings of this study will help the investigators developping new tests to monitor affected patients and optimize the operation as well as the follow-up procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of isolated coarctation of the aorta, or accompanied with atrial septal defect(ASD), ventricular septal defect (VSD), patent ductus arteriosus( PDA), patent foramen ovale (PFO);
- •Patients who can cooperation with study procedures.
排除标准
- •Co-morbidities that may independently affect cardiovascular function, including associated complicated congenital heart disease, such as hypoplastic left heart syndrome (HLHS), interruption of aortic arch (IAA), Shone Syndrome, moderate and severe mitral stenosis;
- •History of known vasculopathy, genetic syndromes, diabetes mellitus, hyperlipoidemia or other cardiovascular risk factors.
结局指标
主要结局
Change in left ventricular mass
时间窗: Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort)
Left ventricular mass will be measured by 2D echocardiography. For the retrospective cohort, the data is collected from the cases' medical record, and during follow-up visit.
Hypertension
时间窗: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Both resting blood pressure and exercise-related blood pressure will be assessed for patients above 5 years old during the follow-up visit.
次要结局
- Left ventricular systolic function(one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort)
- Exercise tolerance(one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort)
- Biomarkers of left ventricle remodeling(For the retrospective cohort, follow-up visit of 1 month to 20 years after primary treatment. For the prospective cohort, the data is collected prior to primary treatment and during follow-up visit of one year after primary treatment)
- Left ventricular diastolic function(one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort)
- Recoarctation(one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort)
- Left ventricular systolic heart function of longitudinal myocardium(one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort)
- Biomarkers of left heart function(Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort))
- Biomarkers of vascular inflammation(Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort))
- All-cause death(20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort)
- Biomarkers of hypertension phenotype related to aortic coarctation(one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort)