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NCT03347214 Clinical Trial

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
Phase
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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