NCT04011956

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

3.8 years

First QC Date

July 4, 2019

Last Update Submit

July 13, 2020

Conditions

Coarctation of Aorta

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • Left ventricular systolic function

    one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort

  • Left ventricular diastolic function

    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

  • Exercise tolerance

    one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment 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)

  • +5 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

If a blood specimen is obtained, it will be separated and stored at -80 ℃ as plasma, viable cells, and extracted DNA. If a saliva specimen is obtained, it is stored for DNA. If a tissue specimen is obtained, it will be cut into small pieces and stored at liquid nitrogen.

MeSH Terms

Conditions

Aortic Coarctation

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jie DU, PhD

    Beijing Institute of Heart, Lung and Blood Vessel Diseases

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan WANG, PhD

CONTACT

86-010-64456169wangyuan980510@163.com

Yan GU, PhD

CONTACT

86-010-64456874echoguyan@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2019

First Posted

July 9, 2019

Study Start

March 1, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations

CN(1)