Conotruncal Cardiac Defects and Nutrigenetic Etiopathogeny

Conotruncal Cardiac Defects Clinical Trial

— CCOMET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01460316
• Other study ID #: 2011-A00346-35
• Status: Completed
• Phase: N/A
• First received: October 25, 2011
• Last updated: January 26, 2016
• Start date: October 2011

Study information

• Verified date: January 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Month and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Conotruncal Cardiac Defects
• Heart Defects, Congenital

Intervention

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

Locations

Country	Name	City	State
France	Service de Cardiologie Pédiatrique, CHU Brabois Enfants	Vandoeuvre les Nancy

Sponsors (5)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Centre Hospitalier Universitaire de Besancon, Centre Hospitalier Universitaire Dijon, CHU de Reims, University Hospital, Strasbourg, France

Country where clinical trial is conducted

France,