dbGaP Protocol: The Pediatric Cardiac Genetics Consortium (PCGC)

Congenital Heart Disease Clinical Trial

Official title:

dbGaP Protocol: The Pediatric Cardiac Genetics Consortium (PCGC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03347214
• Other study ID #: 999918006
• Secondary ID: 18-H-N006
• Status: Completed
• Start date: October 20, 2017
• Est. completion date: January 10, 2020

Study information

• Verified date: January 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background:

Researchers do not know much about the causes of congenital heart disease (CHD). They do know that many factors play a role. Some factors are environmental. Some are genetic. But few specific factors have been identified. And researchers do not know how many involve genes. They want to study data that has already been collected from people with CHD and their families.

Objectives:

To identify genetic variations related to CHD. To study molecules related to vascular disease in order to learn new ways to treat it.

Eligibility:

People who already participated in the Pediatric Cardiac Genomics Consortium (PCGC) study

Design:

Researchers will study data that was already collected in the PCGC. There will be no active participants.

Researchers will get access to the data through the coordinating center. They will not download data to local storage devices.

The data will have no personally identifying information....

Description:

Current understanding of the causes of congenital heart disease (CHD) is limited, but CHD is known to be multifactorial and affected by a combination of environmental, teratogenic, and genetic causes. Furthermore, both genetic and environmental factors have been proposed to act as disease modifiers, accounting for a wide variation in phenotypic expression and clinical outcomes of these disorders. To date however, few specific genetic or environmental causative factors have been identified, nor is it even known what proportion of cases involve genetic factors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6260
• Est. completion date: January 10, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 60 Years

Eligibility

• Retrospective Analysis Study. Data will be analyzed from subjects from cardiovascular disease databases.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Diseases

Locations

Country	Name	City	State
United States	National Heart, Lung and Blood Institute (NHLBI)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of novel genetic variants associated with a CHD phenotype	de novo variants, SNPs, and CNVs	Ongoing