- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01460316
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
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Vandoeuvre les Nancy, France, 54500
- Service de Cardiologie Pédiatrique, CHU Brabois Enfants
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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
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There will be one blood sampling for the nutritionnal, metabolic and genetic parameters studied in the protocol
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Mothers of patients
|
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
Collaborators
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
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.
Clinical Trials on Conotruncal Cardiac Defects
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