Congenital Heart DiseaseSTICNCT02970071
The Application Value of STIC in the Diagnosis of Fetal Complex Congenital Heart Disease
An observational study of Congenital Heart Disease, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The objective of this study is to use of STIC technology to assist the traditional echocardiography to diagnose the fetal congenital heart disease accurately and then to provide a basis for prenatal counseling. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 265 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2017to Dec 2020
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Gravidas with singleton pregnancy living in SHANGHAI
Who may be able to join
- Gravida with singleton pregnancy taking fetal echocardiography.
- No virus infection or drug use history, no harmful substances in the early pregnancy.
- Complete pregnancy check in the hospital, and finally delivery or abortion in the hospital.
- On the basis of informed consent，willing to cooperate with our group.
Who cannot join
- Elderly pregnant women (>35 years old)
- Twin or multiple pregnancy
- Pregnant women suffering from mental illness, can't take care of themselves.
- Fetus diagnosed with other abnormalities (except congenital heart defects)
Trial locations and contacts
1 site in 1 country.
Sun Kun, MD contact
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital,Shanghai Jiao Tong University School of Medicine
Yangpu, Shanghai Municipality, 200092
Sun Chen, MD
About this study
The objective of this study is to use of STIC technology to assist the traditional echocardiography to diagnose the fetal congenital heart disease accurately and then to provide a basis for prenatal counseling.
Read the detailed description
This is a diagnostic test in Shanghai Xinhua hospital from Nov.2016 to Dec.2017. 265 Cases are gravidas with fetal congenital heart disease diagnosed by echocardiography.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.We collect their fetal 2D echocardiography and STIC images every 4-6 weeks during pregnancy and 1 weeks after the baby giving birth we finish their neonatal echocardiography.
- Conditions
- Congenital Heart Disease
- Keywords
- Spatio-Temporal Image Correlation, Complicated congenital heart disease, Echocardiography
- 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 |
|---|---|---|
| Fetal congenital heart disease cases | Gravidas with fetal congenital heart disease diagnosed by fetal echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal Congenital heart disease
If an enrolled gravida chooses to terminate her pregnancy, autopsy confirmation will be performed ;If the gravida continues her pregnancy, the outcome will be measured by neonatal echocardiography or surgery.
Measured: Nov 2016 to Dec 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start25 Apr 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Prospective
- Enrolment
- 265 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinhua Hospital Shanghai Jiao Tong University School of Medicine, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970071
- Sponsor's protocol ID
- XH-16-036
- Acronym
- STIC
- Status last verified
- Sep 2018
- First submitted
- 18 Nov 2016
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Wren C, Reinhardt Z, Khawaja K. Twenty-year trends in diagnosis of life-threatening neonatal cardiovascular malformations. Arch Dis Child Fetal Neonatal Ed. 2008 Jan;93(1):F33-5. doi: 10.1136/adc.2007.119032. Epub 2007 Jun 7.
PubMed 17556383Kim N, Friedberg MK, Silverman NH. Diagnosis and prognosis of fetuses with double outlet right ventricle. Prenat Diagn. 2006 Aug;26(8):740-5. doi: 10.1002/pd.1500.
PubMed 16807954DeVore GR, Falkensammer P, Sklansky MS, Platt LD. Spatio-temporal image correlation (STIC): new technology for evaluation of the fetal heart. Ultrasound Obstet Gynecol. 2003 Oct;22(4):380-7. doi: 10.1002/uog.217.
PubMed 14528474
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application Value of STIC in the Diagnosis of Fetal Complex Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT02970071
- Acronym / sponsor ID
- STIC / XH-16-036
- Conditions
- Congenital Heart Disease
- Keywords
- Spatio-Temporal Image Correlation, Complicated congenital heart disease, Echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 265 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 21 Nov 2016 (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 use of STIC technology to assist the traditional echocardiography to diagnose the fetal congenital heart disease accurately and then to provide a basis for prenatal counseling.
Detailed description
This is a diagnostic test in Shanghai Xinhua hospital from Nov.2016 to Dec.2017. 265 Cases are gravidas with fetal congenital heart disease diagnosed by echocardiography.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.We collect their fetal 2D echocardiography and STIC images every 4-6 weeks during pregnancy and 1 weeks after the baby giving birth we finish their neonatal echocardiography.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fetal congenital heart disease cases | – | –Gravidas with fetal congenital heart disease diagnosed by fetal echocardiography |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Gravidas with singleton pregnancy living in SHANGHAI
Key inclusion criteria (4 listed)
- Gravida with singleton pregnancy taking fetal echocardiography.
- No virus infection or drug use history, no harmful substances in the early pregnancy.
- Complete pregnancy check in the hospital, and finally delivery or abortion in the hospital.
- On the basis of informed consent，willing to cooperate with our group.
Key exclusion criteria (4 listed)
- Elderly pregnant women (>35 years old)
- Twin or multiple pregnancy
- Pregnant women suffering from mental illness, can't take care of themselves.
- Fetus diagnosed with other abnormalities (except congenital heart 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
Fetal Congenital heart disease
Time frame: Nov 2016 to Dec 2018
If an enrolled gravida chooses to terminate her pregnancy, autopsy confirmation will be performed ;If the gravida continues her pregnancy, the outcome will be measured by neonatal echocardiography or surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Results publication: PubMed 17556383Wren C, Reinhardt Z, Khawaja K. Twenty-year trends in diagnosis of life-threatening neonatal cardiovascular malformations. Arch Dis Child Fetal Neonatal Ed. 2008 Jan;93(1):F33-5. doi: 10.1136/adc.2007.119032. Epub 2007 Jun 7.
- Results publication: PubMed 16807954Kim N, Friedberg MK, Silverman NH. Diagnosis and prognosis of fetuses with double outlet right ventricle. Prenat Diagn. 2006 Aug;26(8):740-5. doi: 10.1002/pd.1500.
- Results publication: PubMed 14528474DeVore GR, Falkensammer P, Sklansky MS, Platt LD. Spatio-temporal image correlation (STIC): new technology for evaluation of the fetal heart. Ultrasound Obstet Gynecol. 2003 Oct;22(4):380-7. doi: 10.1002/uog.217.
- Individual participant dataSharing planned: Undecided
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.
Sun Kun, MD contact
Xinhua Hospital Shanghai Jiao Tong University School of Medicine principal investigator
Investigator
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 Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 4 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: status not confirmed, as of the sponsor's last update on 26 Oct 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 Chen Sun, MD (8621-25078485, chengsun@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal Congenital heart disease (time frame: Nov 2016 to Dec 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02970071, which also lists 3 linked publications.
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 26 Oct 2018.