NCT03347214

Brief 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....

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

2.2 years

First QC Date

November 17, 2017

Last Update Submit

January 16, 2020

Conditions

Congenital Heart Disease

Keywords

dbGaP

Outcome Measures

Primary Outcomes (1)

  • Identification of novel genetic variants associated with a CHD phenotype

    de novo variants, SNPs, and CNVs

    Ongoing

Study Arms (1)

1

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

Eligibility Criteria

AgeUp to 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

People who already participated in the Pediatric Cardiac Genomics Study

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jonathan R Kaltman, M.D.

    National Heart, Lung, and Blood Institute (NHLBI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2017

First Posted

November 20, 2017

Study Start

October 20, 2017

Primary Completion

January 10, 2020

Study Completion

January 10, 2020

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

US(1)