NCT01460316

Brief Summary

The investigators planned to study the etiopathogenic factors of conotruncal cardiac defects regarding the relations between the metabolic, the genetic and the environmental factors which lead to these cardiopathy.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

3.6 years

First QC Date

October 25, 2011

Last Update Submit

January 26, 2016

Conditions

Conotruncal Cardiac Defects

Keywords

Conotruncal cardiac defectsmethylationgenotypecobalaminfolatesnutrition

Study Arms (2)

Conotruncal cardiac defects patients

Biological: Bood sampling for biochemicals and genetic analysis

Mothers of patients

Biological: Bood sampling for biochemicals and genetic analysis

Interventions

Bood sampling for biochemicals and genetic analysisBIOLOGICAL

There will be one blood sampling for the nutritionnal, metabolic and genetic parameters studied in the protocol

Conotruncal cardiac defects patientsMothers of patients

Eligibility Criteria

Age1 Month+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Conotruncal cardiac defects population and theirs mothers

You may qualify if:

  • Conotruncal cardiac defects patients and theirs mothers
  • Weight: \> 3750 g

You may not qualify if:

  • Syndromic conotruncal cardiac defects
  • q11 deletion Holder's
  • Patients whose mother's took anti-folates before and during first pregnancy semester

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Cardiologie Pédiatrique, CHU Brabois Enfants

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Conotruncal cardiac defects

Interventions

Genetic Testing

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • François FEILLET, MD-PHD

    CHU de Nancy- Hôpital Brabois Enfants

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, M.D. Ph.D

Study Record Dates

First Submitted

October 25, 2011

First Posted

October 26, 2011

Study Start

October 1, 2011

Primary Completion

May 1, 2015

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations

FR(1)