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Trial record 1 of 3 for:    "Conotruncal heart malformations"
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Conotruncal Cardiac Defects and Nutrigenetic Etiopathogeny (CCOMET)

This study has been completed.
Sponsor:
Collaborators:
Centre Hospitalier Universitaire de Besancon
University Hospital, Strasbourg, France
Centre Hospitalier Universitaire Dijon
CHU de Reims
Information provided by (Responsible Party):
FEILLET François, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01460316
First received: October 25, 2011
Last updated: January 26, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention
Conotruncal Cardiac Defects Biological: Bood sampling for biochemicals and genetic analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Conotruncal Cardiac Defects and Metabolism, Nutrigenetic Factors of Etiopathogeny of Conotruncal Cardiac Defects

Resource links provided by NLM:


Further study details as provided by FEILLET François, Central Hospital, Nancy, France:

Enrollment: 400
Study Start Date: October 2011
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Month and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Conotruncal cardiac defects population and theirs mothers
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01460316

Locations
France
Service de Cardiologie Pédiatrique, CHU Brabois Enfants
Vandoeuvre les Nancy, France, 54500
Sponsors and Collaborators
Central Hospital, Nancy, France
Centre Hospitalier Universitaire de Besancon
University Hospital, Strasbourg, France
Centre Hospitalier Universitaire Dijon
CHU de Reims
Investigators
Principal Investigator: François FEILLET, MD-PHD CHU de Nancy- Hôpital Brabois Enfants
  More Information

Responsible Party: FEILLET François, Professor, M.D. Ph.D, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01460316     History of Changes
Other Study ID Numbers: 2011-A00346-35
Study First Received: October 25, 2011
Last Updated: January 26, 2016

Keywords provided by FEILLET François, Central Hospital, Nancy, France:
Conotruncal cardiac defects
methylation
genotype
cobalamin
folates
nutrition

Additional relevant MeSH terms:
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on June 26, 2017