Prognosis and Integrative Assessment of Aortic Coarctation Patients in China

Study Overview
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Brief Summary
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This is a systemic research of Chinese aortic coarctation patients, aiming to determine risk factors and serial biomarkers of aortic coarctation in prognosis.

Detailed Description
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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.

Official Title
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Prognosis and Integrative Assessment of Aortic Coarctation Patients in CHINA

Conditions
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Coarctation of Aorta

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective Cohort of Aortic Coarctation<br>Patients diagnosed as aortic coarctation and undergone corrected procedures from 2002 to Feb 28th 2019 were recruited in Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography. | |
| Perspective Cohort of Aortic Coarctation<br>Patients diagnosed as aortic coarctation and undergone corrected procedures after Mar. 1st 2019 will be recruited in Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in left ventricular mass | 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. | Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort) | 
| Hypertension | Both resting blood pressure and exercise-related blood pressure will be assessed for patients above 5 years old during the follow-up visit. | one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular systolic function | Left ventricular systolic function assessed by echocardiography | one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort | 
| Left ventricular diastolic function | Left ventricular diastolic function assessed by echocardiography (TDI) | 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 | Left ventricular systolic heart function of longitudinal myocardium assessed by echocardiography (M mode Doppler). | one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort | 
| Exercise tolerance | Six minutes walking distance will be recorded and analyzed to evaluate the exercise tolerance. Echocardiographic images will be obtained after six minutes walking to assess the reserve function of left ventricle. Blood pressure will also be taken immediately after the Six minutes walking to analyze exercise-induced hypertension. | one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort | 
| Biomarkers of vascular inflammation | Biomarkers of inflammation (hs-CRP). For the retrospective cohort, the data is collected from the cases' medical record, and during follow-up visit. | 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 left ventricle remodeling | Biomarkers of left ventricle remodeling (ST2) | 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 | 
| Biomarkers of left heart function | Biomarkers of left heart function (BNP). For the retrospective cohort, the data is collected from the cases' medical record, and during follow-up visit. | 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 hypertension phenotype related to aortic coarctation | 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 | 
| Recoarctation | Recoarctation assessed by echocardiography or computed tomography angiography. | one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort | 
| All-cause death | The data is collected during follow-up visit at follow-up time point. | 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort |