Conotruncal Cardiac Defects and Nutrigenetic Etiopathogeny (CCOMET)

January 26, 2016 updated by: FEILLET François, Central Hospital, Nancy, France

Conotruncal Cardiac Defects and Metabolism, Nutrigenetic Factors of Etiopathogeny of Conotruncal Cardiac Defects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandoeuvre les Nancy, France, 54500
        • Service de Cardiologie Pédiatrique, CHU Brabois Enfants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Conotruncal cardiac defects population and theirs mothers

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Syndromic conotruncal cardiac defects
  • 22q11 deletion Holder's
  • Patients whose mother's took anti-folates before and during first pregnancy semester

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Conotruncal cardiac defects patients
Biological: Bood sampling for biochemicals and genetic analysis
There will be one blood sampling for the nutritionnal, metabolic and genetic parameters studied in the protocol
Mothers of patients
Biological: Bood sampling for biochemicals and genetic analysis
There will be one blood sampling for the nutritionnal, metabolic and genetic parameters studied in the protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Collaborators

University Hospital, Strasbourg, France
Centre Hospitalier Universitaire Dijon
CHU de Reims
Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: François FEILLET, MD-PHD, CHU de Nancy- Hôpital Brabois Enfants

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

October 25, 2011

First Submitted That Met QC Criteria

October 25, 2011

First Posted (Estimate)

October 26, 2011

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-A00346-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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