NCT05203874

Brief Summary

The CT-Coarct-PED study is a multicentred observational study aiming to describe the population of early coarctation during the last 10 years in South of France. The secondary objective is to assess the importance of cross-sectional imaging in the surgical management of aortic coarctation in the first year of life

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
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 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

January 1, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2022

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

11 months

First QC Date

January 10, 2022

Last Update Submit

January 24, 2022

Conditions

Aortic CoarctationCongenital Heart Disease

Keywords

Multimodal imagingNeonatal coarctationRadiation protection

Outcome Measures

Primary Outcomes (1)

  • Description of all cases of neonatal coarctations

    Description of all cases of neonatal coarctations in 4 surgical centers (Bordeaux Marseille, Nantes and Toulouse) over the years 2011 to 2021

    day 1

Secondary Outcomes (2)

  • Level of agreement between the surgical procedure envisaged

    day 1

  • Level of agreement between the surgical procedure envisaged

    day 1

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

all newborns who have had coarctation surgery during the first month of life in one of the four center included during the period between 2011 and 2021

You may qualify if:

  • Patients \<1 years old
  • Aortic coarctation in the first year of life
  • Surgical management in one of the four participating centers
  • No associated heart defect

You may not qualify if:

  • \- age \> 1 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Aortic CoarctationHeart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Oscar WERNER, MD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar WERNER, MD

CONTACT

467336632o-werner@chu-montpellier.fr

Sophie Guillaumont, MD

CONTACT

467336632s-guillaumont@chu-montpellier.fr

Study Design

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

Study Record Dates

First Submitted

January 10, 2022

First Posted

January 24, 2022

Study Start

January 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 29, 2022

Last Updated

February 1, 2022

Record last verified: 2022-01

Locations

FR(1)