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Conotruncal Cardiac Defects and Nutrigenetic Etiopathogeny (CCOMET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01460316
Recruitment Status : Completed
First Posted : October 26, 2011
Last Update Posted : January 27, 2016
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

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.

Condition or disease Intervention/treatment
Conotruncal Cardiac Defects Biological: Bood sampling for biochemicals and genetic analysis

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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Conotruncal Cardiac Defects and Metabolism, Nutrigenetic Factors of Etiopathogeny of Conotruncal Cardiac Defects
Study Start Date : October 2011
Actual Primary Completion Date : May 2015

Resource links provided by the National Library of Medicine


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





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Ages Eligible for Study:   1 Month and older   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460316


Locations
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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
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Principal Investigator: François FEILLET, MD-PHD CHU de Nancy- Hôpital Brabois Enfants
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Responsible Party: FEILLET François, Professor, M.D. Ph.D, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01460316    
Other Study ID Numbers: 2011-A00346-35
First Posted: October 26, 2011    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016
Keywords provided by FEILLET François, Central Hospital, Nancy, France:
Conotruncal cardiac defects
methylation
genotype
cobalamin
folates
nutrition
Additional relevant MeSH terms:
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Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities