Congenital Heart DiseaseSCPRFGBCHDNCT01669057
Study on Clinical Prognosis, Risk Factors and Genetic Basis of Congenital Heart Disease
An observational study of Congenital Heart Disease, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
The objective of this study is to investigate the effect of parental peri-natal environmental risk factors and genetic factors on the development of Congenital Heart Disease (CHD). Read more about this study
- Who is it for?
- Ages Up to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- Oct 2011to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The population is from two ongoing projects- "Key Clinical Research Project Sponsored by Ministry of Health Screening, evaluation and intervention of congenital heart disease in newborn infants(2010-239)" and "Health and Public Welfare Research Project Sponsored by Ministry of Health of China Screening and evaluation of congenital heart disease in children of under 3 years old in the countryside(20102006)"
Who may be able to join
- Han ethnic
- 0~3 years old
- screened by 7 indicator, diagnosed by ultrasound
- Han ethnic
- 0~3 years old
- without any of 7 screen indicator , without CHD heart palpitations and other complaints about heart disease, born in the same hospital with cases
Who cannot join
- with other brith defects
- with Patent Ductus Arteriosus (PDA) and Patent Foramen Ovale (PFO)
- Control group
- With other birth defects
Trial locations and contacts
1 site in 1 country.
China1 site
Children Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Case-control Study on Environmental and Genetic Factors of Congenital Heart Disease
The objective of this study is to investigate the effect of parental peri-natal environmental risk factors and genetic factors on the development of Congenital Heart Disease (CHD). Our hypothesis is that the distributions of some environmental and genetic risk factors significantly differ between neonates with and without CHD.
Read the detailed description
Congenital heart defect (CHD) is one of birth defects in the structure of the heart and/or great vessels. Many types of heart defects exist, most of which either obstruct blood flow in the heart or vessels near it, or cause blood to flow through the heart in an abnormal pattern. Heart defects are the leading cause of birth defect-related infant deaths. So far people recognize that the causes of CHD are the conjunct effect of environment and genetic factors, both of which remain unclear. The current stud aims at investigating all the possible perinatal parental environmental risk factors and underlying genetic factors to CHD, including DNA variation and methylations. A hospital-based 1:1 matched case control study is conducted. Subjects were recruited through neonatal screening program, which includes a clinical symptom screening followed by a cardiac ultrasound diagnosis for those with at least one clinical indicator. The blood sample of participant will be collected and the parents of subjects will be interviewed to completed a questionnaire including general information and possible risk factors to CHD.
- Conditions
- Congenital Heart Disease
- Keywords
- Congenital heart disease, DNA variation, methylation, risk factors, supplements
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Congenital heart defect（CHD） group | Not described | |
| Normal control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
genome-wide DNA SNPs and methylations
DNA sample from neonate blood
Measured: delivery
perinatal supplements and drug using
questionnaire including supplements and drug using for mother
Measured: three months before pregnancy till delivery
Secondary outcomes (4)
Life risk factors of mother
smoking, drinking, health, family history
Measured: three months before pregnancy till delivery
Life risk factors of father
smoking, drinking, health, family history
Measured: three months before pregnancy till delivery
gestational weeks
Measured: delivery
birth weight
Measured: delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startOct 2011
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo Women & Children's Hospital, Changzhou Maternal and Child Care Hospital, Maternal and Child Health Hospital of Taian, Maternal and Child Health Hospital of Wuxi, Kunshan City Maternal and Child Health, The First Affiliated Hospital of Xiamen University, Maternal and Child Health Hospital, Jiading District, Minhang Maternal and Children Health Care Hospital
- Responsible party
- Principal investigator, Guoying huang, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669057
- Sponsor's protocol ID
- KY2011-366
- Acronym
- SCPRFGBCHD
- Status last verified
- Mar 2015
- First submitted
- 16 Aug 2012
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case-control Study on Environmental and Genetic Factors of Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT01669057
- Acronym / sponsor ID
- SCPRFGBCHD / KY2011-366
- Conditions
- Congenital Heart Disease
- Keywords
- Congenital heart disease, DNA variation, methylation, risk factors, supplements
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Ningbo Women & Children's Hospital, Changzhou Maternal and Child Care Hospital, Maternal and Child Health Hospital of Taian, Maternal and Child Health Hospital of Wuxi, Kunshan City Maternal and Child Health, The First Affiliated Hospital of Xiamen University, Maternal and Child Health Hospital, Jiading District, Minhang Maternal and Children Health Care Hospital
- Study start
- Oct 2011
- Study completion
- Aug 2014 (actual)
- First posted
- 20 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to investigate the effect of parental peri-natal environmental risk factors and genetic factors on the development of Congenital Heart Disease (CHD). Our hypothesis is that the distributions of some environmental and genetic risk factors significantly differ between neonates with and without CHD.
Detailed description
Congenital heart defect (CHD) is one of birth defects in the structure of the heart and/or great vessels. Many types of heart defects exist, most of which either obstruct blood flow in the heart or vessels near it, or cause blood to flow through the heart in an abnormal pattern. Heart defects are the leading cause of birth defect-related infant deaths. So far people recognize that the causes of CHD are the conjunct effect of environment and genetic factors, both of which remain unclear. The current stud aims at investigating all the possible perinatal parental environmental risk factors and underlying genetic factors to CHD, including DNA variation and methylations. A hospital-based 1:1 matched case control study is conducted. Subjects were recruited through neonatal screening program, which includes a clinical symptom screening followed by a cardiac ultrasound diagnosis for those with at least one clinical indicator. The blood sample of participant will be collected and the parents of subjects will be interviewed to completed a questionnaire including general information and possible risk factors to CHD.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Congenital heart defect（CHD） group | – | – |
| Normal control group | – | – |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The population is from two ongoing projects- "Key Clinical Research Project Sponsored by Ministry of Health Screening, evaluation and intervention of congenital heart disease in newborn infants(2010-239)" and "Health and Public Welfare Research Project Sponsored by Ministry of Health of China Screening and evaluation of congenital heart disease in children of under 3 years old in the countryside(20102006)"
Key inclusion criteria (6 listed)
- Han ethnic
- 0~3 years old
- screened by 7 indicator, diagnosed by ultrasound
- Han ethnic
- 0~3 years old
Key exclusion criteria (4 listed)
- with other brith defects
- with Patent Ductus Arteriosus (PDA) and Patent Foramen Ovale (PFO)
- Control group
- With other birth defects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
genome-wide DNA SNPs and methylations
Time frame: delivery
DNA sample from neonate blood
perinatal supplements and drug using
Time frame: three months before pregnancy till delivery
questionnaire including supplements and drug using for mother
4 secondary outcomes
Life risk factors of mother
Time frame: three months before pregnancy till delivery
Life risk factors of father
Time frame: three months before pregnancy till delivery
gestational weeks
Time frame: delivery
birth weight
Time frame: delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
Related trials for Congenital Heart Disease
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
genome-wide DNA SNPs and methylations (time frame: delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015.