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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Central Hospital, Nancy, France.
Recruitment status was  Recruiting
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: NA
Last verified: October 2011
History: No changes posted
  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

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

Estimated Enrollment: 800
Study Start Date: October 2011
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
Genders Eligible for Study:   Both
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

Contacts
Contact: François FEILLET, MD, PHD +33 3 83 15 47 96 f.feillet@chu-nancy.fr
Contact: Laurent BONNEMAINS, MD +33 3 83 15 46 41 l.bonnemains@chu-nancy.fr

Locations
France
Service de Cardiologie Pédiatrique, CHU Brabois Enfants Recruiting
Vandoeuvre les Nancy, France, 54500
Contact: François Feillet, MD, PHD    + 33 3 83 15 47 96    f.feillet@chu-nancy.fr   
Contact: Laurent Bonnemains, MD    + 33 3 83 15 46 41    l.bonnemains@chu-nancy.fr   
Sub-Investigator: Laurent Bonnemains, MD         
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

No publications provided

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: October 25, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by 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 July 22, 2014