Prognosis and Integrative Assessment of Aortic Coarctation Patients in China

NCT ID: NCT04011956

Last Updated: 2020-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2023-12-31

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.

Conditions

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Coarctation of Aorta

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role collaborator

Bayi Children's Hospital Affiliated to PLA Army General Hospital, China

OTHER

Sponsor Role collaborator

Capital Institute of Pediatrics, China

OTHER

Sponsor Role collaborator

Beijing Institute of Heart, Lung and Blood Vessel Diseases

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jie DU, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Institute of Heart, Lung and Blood Vessel Diseases

Locations

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Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuan WANG, PhD

Role: CONTACT

86-010-64456169

Yan GU, PhD

Role: CONTACT

86-010-64456874

Facility Contacts

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Yuan WANG, PhD

Role: primary

86-010-64456169

Yan GU, PhD

Role: backup

86-010-64456874

Other Identifiers

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PICC

Identifier Type: -

Identifier Source: org_study_id

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