Congenital Heart DiseaseNCT03119155
Improvement on Diagnosis of Fetal Congenital Heart Disease Based on Multi-center Collaboration in China
An observational study of Congenital Heart Disease and Echocardiography, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
The objective of this study is to improve the diagnosis level of fetal congenital heart disease by the multi-center collaboration in China. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Congenital Heart Disease, Echocardiography, Diagnosis
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 31 Dec 2021
- How long will I take part?
- 2 Years
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Gravidas with singleton pregnancy with congenital heart disease
Who may be able to join
- 1.Gravida with singleton pregnancy with congenital heart disease taking fetal echocardiography in 16th-24nd of gestational weeks.
- 2.Complete pregnancy check in Beijing Anzhen Hospital and the hospitals contained in our multi-center network collaboration, and finally delivery or abortion in these hospitals.
- 3.Willing to cooperate with our study.
Who cannot join
- 1. Pregnant women with serious pregnancy complications and suffering from mental illness.
- 2.Pregnant women not willing to cooperate
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijng Anzhen Hospital
Beijing, Beijing Municipality, 100029
Yanping Ruan, MD, +86 15311258732, yanping.ruan@163.com
About this study
The objective of this study is to improve the diagnosis level of fetal congenital heart disease by the multi-center collaboration in China.
Read the detailed description
Our center has constructed multi-center collaborative network in 2013, so far which contains more than 170 maternal and child health care hospitals throughout the whole of China. This is a multi-center-based study to improve the integral diagnostic level of fetal congenital heart diseases by fetal echocardiography. Sixty pregnant cases (18-45 years) whose fetuses with heart abnormalities will be recruited in a successive manner from every center every year. Cases are gravidas with fetal congenital heart disease diagnosed by echocardiography in 16th-24th of gestational weeks. Every center will upload the echocardiography materials and the diagnostic reports so that another two experienced echocardiography physicians confirm the diagnosis based on these materials in a double-blinded method. In addition, the golden standard of congenital heart disease depends on the autopsy, heart and vascular casting after abortion and operation after birth. The investigators will provide the report about the rate of missed diagnosis and misdiagnosis and the periodical training on fetal echocardiography for every center every half an year. Only gravidas who are willing to have complete pregnancy checks and finally delivery or abortion in the hospital are interviewed are eligible for the study. Study participants will be asked for their informed consent.
- Conditions
- Congenital Heart Disease, Echocardiography, Diagnosis
- Keywords
- Congenital Heart Disease, Echocardiography, Diagnosis
- Medical subject headings
- Heart Defects, Congenital, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of missed diagnosis and misdiagnosis
We will report the primary outcome every year, and compare the change trend of diagnostic level of fetal congenital heart disease
Measured: From Jan 2018 to Dec 2020
Secondary outcomes (1)
The prognosis of different type of fetal congenital heart disease with 1 year after birth
We will get the abortion rate of different types of fetal congenital heart disease and operation rate within 1 year after birth.
Measured: From Jan 2018 to Dec 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start1 Dec 2018 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
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 Beijing Anzhen HospitalThe 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Yihua,MD, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119155
- Sponsor's protocol ID
- FCHD-CHINA01
- Status last verified
- Aug 2018
- First submitted
- 13 Apr 2017
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement on Diagnosis of Fetal Congenital Heart Disease Based on Multi-center Collaboration in China
- ClinicalTrials.gov ID
- NCT03119155
- Acronym / sponsor ID
- FCHD-CHINA01
- Conditions
- Congenital Heart Disease, Echocardiography, Diagnosis
- Keywords
- Congenital Heart Disease, Echocardiography, Diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 18 Apr 2017 (actual)
- 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 improve the diagnosis level of fetal congenital heart disease by the multi-center collaboration in China.
Detailed description
Our center has constructed multi-center collaborative network in 2013, so far which contains more than 170 maternal and child health care hospitals throughout the whole of China. This is a multi-center-based study to improve the integral diagnostic level of fetal congenital heart diseases by fetal echocardiography. Sixty pregnant cases (18-45 years) whose fetuses with heart abnormalities will be recruited in a successive manner from every center every year. Cases are gravidas with fetal congenital heart disease diagnosed by echocardiography in 16th-24th of gestational weeks. Every center will upload the echocardiography materials and the diagnostic reports so that another two experienced echocardiography physicians confirm the diagnosis based on these materials in a double-blinded method. In addition, the golden standard of congenital heart disease depends on the autopsy, heart and vascular casting after abortion and operation after birth. The investigators will provide the report about the rate of missed diagnosis and misdiagnosis and the periodical training on fetal echocardiography for every center every half an year. Only gravidas who are willing to have complete pregnancy checks and finally delivery or abortion in the hospital are interviewed are eligible for the study. Study participants will be asked for their informed consent.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Gravidas with singleton pregnancy with congenital heart disease
Key inclusion criteria (3 listed)
- 1.Gravida with singleton pregnancy with congenital heart disease taking fetal echocardiography in 16th-24nd of gestational weeks.
- 2.Complete pregnancy check in Beijing Anzhen Hospital and the hospitals contained in our multi-center network collaboration, and finally delivery or abortion in these hospitals.
- 3.Willing to cooperate with our study.
Key exclusion criteria (2 listed)
- 1. Pregnant women with serious pregnancy complications and suffering from mental illness.
- 2.Pregnant women not willing to cooperate
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
the rate of missed diagnosis and misdiagnosis
Time frame: From Jan 2018 to Dec 2020
We will report the primary outcome every year, and compare the change trend of diagnostic level of fetal congenital heart disease
1 secondary outcome
The prognosis of different type of fetal congenital heart disease with 1 year after birth
Time frame: From Jan 2018 to Dec 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
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 and Echocardiography, run by Beijing Anzhen Hospital 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yihua He, MD (+86 18910778673, heyihuaecho@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of missed diagnosis and misdiagnosis (time frame: From Jan 2018 to Dec 2020). 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 20 Aug 2018.