Prognosis and Integrative Assessment of Aortic Coarctation Patients in China

Prognosis and Integrative Assessment of Aortic Coarctation Patients in CHINA

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

Study Overview

• Status: Recruiting
• Conditions: Coarctation of Aorta

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Yan GU, PhD; Phone Number: 86-010-64456874; Email: echoguyan@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • Beijing Anzhen Hospital
      • Contact: Yan GU, PhD; Phone Number: 86-010-64456874; Email: echoguyan@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with coarctation of the aorta, treated after 2002 in Beijing Anzhen Hospital.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Retrospective Cohort of Aortic Coarctation; 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; 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?

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

Collaborators and Investigators

• Sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
• Collaborators: Beijing Anzhen Hospital; Capital Institute of Pediatrics, China; Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
• Investigators: Principal Investigator: Jie DU, PhD, Beijing Institute of Heart, Lung and Blood Vessel Diseases

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: July 4, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Aortic Coarctation
• Other Study ID Numbers: PICC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No