Congenital Heart DiseaseLIFENCT05090306
Interpretation of Fetal Echocardiography by Artificial Intelligence
An observational study of Congenital Heart Disease, run by University of Medicine and Pharmacy Craiova at 1 site in Romania.
Trial summary
The study to be performed aims to design and develope an automated Intelligent Decision Support System for fetal echocardiography that can significantly assist the obstetric physician in the improvement of detection of fetal congenital heart disease compared to the common standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Routine ultrasound examination
- How many people
- 1,000 participants
- Where
- 1 siteRomania
- Study dates
- 1 Nov 2020to 31 Oct 2022
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All pregnant women of 18 years and above, in their first and second trimester are considered eligible for the study.
Who may be able to join
- pregnant women in their first and second trimester
- signed informed consent for the study
Who cannot join
- unknown outcome of pregnancy
- age under 18 years old
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
University Emergency County Hospital
Craiova, Dolj
Dominic G Iliescu, Assoc. Prof., 723888773 ext. +40, dominic.iliescu@yahoo.com
About this study
Official title: Learning Deep Architectures for the Interpretation of Fetal Echocardiography
The study to be performed aims to design and develope an automated Intelligent Decision Support System for fetal echocardiography that can significantly assist the obstetric physician in the improvement of detection of fetal congenital heart disease compared to the common standard of care.
Read the detailed description
Introduction:
Worldwide, Congenital Heart Disease (CHD) is the most encountered fetal malformation. The incidence of congenital heart disease appears to be about 1 per 100 live born infants and is even higher in infants who die before term (1). Fetal echocardiography (FE) has evolved from just the description of the anatomical abnormalities of the heart toward quantitative assessment of its function, dimension and shape (2). Presently, FE is performed manually by the sonographer during the second trimester investigation. However, only half of the babies undergoing surgery within the first year of life have a prenatal detection (3), explaining the need for an improvement of the fetal cardiac assessment. Many studies showed the presence of a significant discrepancy between the pre- and postnatal diagnosis of the CHD obtained by a manually performed FE (4, 5).
Intelligent Decision Support Systems (ISs) are frameworks that have the capacity to gather and analyze data, communicate with other systems, learn from experience, and adapt according to new cases. Technically speaking, ISs are advanced machines that observe and respond to the environment that they have been exposed to using Artificial Intelligence (AI) (6). This project aims to foster a cross-fertilization of FE and ISs, which will provide an enormous potential in developing new fundamental theories and practical methods that rise above the boundaries of the disciplines involved and lead to new impactful methods that assist medical practice and discovery.
Methods and analysis:
The study to be performed is a cross-sectional study divided into two separated parts: the training part of the machine learning approaches within the proposed framework and the testing phase on previously unseen frames and eventually on actual video scans. All pregnant women in their first and second trimester are considered eligible for the study. Pregnant women will be admitted for their routine ultrasound examination and monitoring, first time between 12-13+6 weeks of pregnancy (for the first trimester anomaly scan) and / or between 18-24 weeks of pregnancy (for the second trimester anomaly scan). Two-dimensional evaluation of each fetal heart will include a cine loop sweep obtained from the from the four-chamber view plane by moving the transducer cranially towards the upper mediastinum, allowing the visualization of the following planes: four-chamber view, left and right ventricular outflow tracts, three vessels and trachea view. All video files saved from the US devices will be collected into the cloud. Each ultrasound sweep will be split into frames by the OB-GYN/Cardio (OBC) department. The Data Science / IT department (DSIT) will process the frames for obeying the anonymization regulations. For key feature identification, the frames will be grouped by the OBC into the classes that represent the plane views for each trimester. DSIT will try different state-of-the-art DL pre-trained algorithms on the data set with plane views. All the recent DL entries will be tailored and tested on the current two scenarios of key view identification and semantic segmentation. Their performance results (their prediction against the ground truth marked by the OBC) will be analyzed in comparison by means of a statistical test. The accuracy-speed equilibrium will be taken into account in the ranking of the approaches, since the system will finally perform on a video. Once a new video will be available in practice, the model chosen for the respective task will highlight the key feature or the segmented region on video and also provide a degree of confidence in its recognition. The OBC physicians will validate all the intermediary findings at frame level, as well as the meaningfulness of the video labelling and segmentation. The outcomes of the model on the first and second trimester videos of the same patient will be compared to assess the discrepancy.
AI (ARTIFICIAL INTELLIGENCE) ANALYSIS
Database construction:
The data set for AI analysis will be constructed from images extracted from ultrasound scans taken in the apical plane. Consequently, a classification problem with four categories corresponding to the given key views is considered. An additional Other class is appointed and populated with images of other unimportant frames from the scan.
Image preprocessing for fetal heart scans:
The first step is represented by the extraction performed by converting the image to gray scale and applying a threshold. In this way, the background noise is discarded. In order to eliminate the small bridges between the area of interest and other areas in the image, erosion is applied using a 10x10 pixels kernel. After erosion, besides the area of interest, several smaller "islands" may appear in the image. The zone of interest has two properties that distinguish it from the rest of the islands: it always covers the central area of the image and it has the highest area. In order to eliminate the non-relevant islands, the spots that cover the central area of the image are first identified, then the spot with the highest surface coverage is selected. The detected spot is filled, then the dimension is restored by applying a dilation algorithm, using the same kernel of 10x10 pixels. In order to prevent losing the fine details around the dilated spot, its convex hull is drawn and filled. In the end, the generated spot is used as a mask to extract the area of interest from the original image.
Experimental results:
Three variants of the data collection are considered: the original double-sided (standard + Doppler) samples, the Doppler single crops and merged image pairs of resulting standard and Doppler crops.
The ResNet18 and ResNet50 architectures, with similar setups, are applied for each data set in turn for evaluating the suitability of the preliminary processing.
As the data collections with cropped images contain representatives from all the initial images, all sets thus have the same number of items and structure per each class, as well as for the training, validation and test separations. For an objective evaluation, all images that are extracted from a patient lie within the same separation of the data set, i.e. training, validation or test. This occurs even if there were multiple video files for a patient made at different moments (e.g. weeks apart) in time.
The images are resized to 224 × 224 pixels. The 1cycle policy is used and the implementation is made using fastai and PyTorch libraries. The initial model weights are taken through transfer learning, as pretrained on the ImageNet data set. The default options for data augmentations are used. There are 2 steps involved in the training process, each containing only 10 epochs. Within the first training session, all layers are frozen, except for the batch normalization layers and the head of the model. Its choice controls how the weights of the network are adjusted with respect to the loss gradient and selecting a proper value is essential for making the model converging to a local minimum, and reaching thus improved accuracy in a smaller amount of epochs. The batch size is taken equal to 32. The model that hits the highest accuracy on the validation data is applied on the test set. For each of the 2 architectures and for each separate data set, 5 repeated applications are made and the reported results for each case are computed as the average over the 5 outcomes. The runs are made in Google Colab, using Tesla T4 for GPU. B. The successful gradient class activation map (Grad-CAM) approach is used for outlining the decisions of the model for the Aorta and Other labelling for each data set. The plots are derived from the 5 runs that are computed for each distinct (architecture, data set) setup.
- Conditions
- Congenital Heart Disease
- Being tested
- Routine ultrasound examination
- Keywords
- Artificial intelligence, Fetal cardiology, Echocardiography, Decision support systems
- 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.
Routine ultrasound examinationDiagnostic test
ULTRASOUND EXAMINATION Women recruited to take part in the study will undergo the routine ultrasound examinations and monitoring, including a fetal echocardiogram between 12-13+6 weeks of gestation (for the first trimester cases) and between 18-24 weeks of gestation (for the second trimester cases). Two-dimensional evaluation of each fetal heart will include a cine loop sweep obtained from the from the four-chamber view plane by moving the transducer cranially towards the upper mediastinum, allowing the visualization of the following planes: four-chamber view, left and right ventricular outflow tracts, three vessels and trachea view. The examination will be stored for further analysis.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women in their first and second trimester | Pregnant women in their first and second trimester will be examined using two-dimensional echocardiography of the fetal heart. Receives: Diagnostic Test: Routine ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of an Intelligent Decision Support System for fetal echocardiography
The primary objective of this study is the design and development of the IS that can significantly assist the physician in the improvement of detection of fetal congenital heart disease compared to the common standard of care.
Measured: 24 months
Secondary outcomes (2)
Counseling aid for newly trained sonographers
The first secondary outcome is to improve the performance of unexperienced and newly trained sonographers regarding the quality in image acquisition.
Measured: 36 months
Improveing the prenatal diagnosis
Another secondary outcome is to reduce the rate of diagnosis discrepancies between first and second trimester evaluations and between pre- and postnatal cardiac assessment.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Nov 2020
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy Craiova
- Sponsor type
- University, hospital or other
- Collaborators
- Romanian Institute of Science and Technology, Cluj-Napoca, Romania, MEDGIN/GINECHO Clinic
- Responsible party
- Sponsor
- Investigators
- Dominic G Iliescu, Assoc. Prof., Study chair, University of Medicine and Pharmacy CraiovaAnda Ungureanu, PhD(c), Study director, University of Medicine and Pharmacy CraiovaRodica Nagy, PhD(c), Principal investigator, University of Medicine and Pharmacy Craiova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090306
- Sponsor's protocol ID
- LIFE
- Acronym
- LIFE
- Status last verified
- Aug 2021
- First submitted
- 11 Oct 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ungureanu A, Marcu AS, Patru CL, Ruican D, Nagy R, Stoean R, Stoean C, Iliescu DG. Learning deep architectures for the interpretation of first-trimester fetal echocardiography (LIFE) - a study protocol for developing an automated intelligent decision support system for early fetal echocardiography. BMC Pregnancy Childbirth. 2023 Jan 11;23(1):20. doi: 10.1186/s12884-022-05204-x.
PubMed 36631859
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Deep Architectures for the Interpretation of Fetal Echocardiography
- ClinicalTrials.gov ID
- NCT05090306
- Acronym / sponsor ID
- LIFE / LIFE
- Conditions
- Congenital Heart Disease
- Keywords
- Artificial intelligence, Fetal cardiology, Echocardiography, Decision support systems
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy CraiovaUniversity, hospital or other
- Collaborators
- Romanian Institute of Science and Technology, Cluj-Napoca, Romania, MEDGIN/GINECHO Clinic
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 22 Oct 2021 (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 study to be performed aims to design and develope an automated Intelligent Decision Support System for fetal echocardiography that can significantly assist the obstetric physician in the improvement of detection of fetal congenital heart disease compared to the common standard of care.
Detailed description
Introduction:
Worldwide, Congenital Heart Disease (CHD) is the most encountered fetal malformation. The incidence of congenital heart disease appears to be about 1 per 100 live born infants and is even higher in infants who die before term (1). Fetal echocardiography (FE) has evolved from just the description of the anatomical abnormalities of the heart toward quantitative assessment of its function, dimension and shape (2). Presently, FE is performed manually by the sonographer during the second trimester investigation. However, only half of the babies undergoing surgery within the first year of life have a prenatal detection (3), explaining the need for an improvement of the fetal cardiac assessment. Many studies showed the presence of a significant discrepancy between the pre- and postnatal diagnosis of the CHD obtained by a manually performed FE (4, 5).
Intelligent Decision Support Systems (ISs) are frameworks that have the capacity to gather and analyze data, communicate with other systems, learn from experience, and adapt according to new cases. Technically speaking, ISs are advanced machines that observe and respond to the environment that they have been exposed to using Artificial Intelligence (AI) (6). This project aims to foster a cross-fertilization of FE and ISs, which will provide an enormous potential in developing new fundamental theories and practical methods that rise above the boundaries of the disciplines involved and lead to new impactful methods that assist medical practice and discovery.
Methods and analysis:
The study to be performed is a cross-sectional study divided into two separated parts: the training part of the machine learning approaches within the proposed framework and the testing phase on previously unseen frames and eventually on actual video scans. All pregnant women in their first and second trimester are considered eligible for the study. Pregnant women will be admitted for their routine ultrasound examination and monitoring, first time between 12-13+6 weeks of pregnancy (for the first trimester anomaly scan) and / or between 18-24 weeks of pregnancy (for the second trimester anomaly scan). Two-dimensional evaluation of each fetal heart will include a cine loop sweep obtained from the from the four-chamber view plane by moving the transducer cranially towards the upper mediastinum, allowing the visualization of the following planes: four-chamber view, left and right ventricular outflow tracts, three vessels and trachea view. All video files saved from the US devices will be collected into the cloud. Each ultrasound sweep will be split into frames by the OB-GYN/Cardio (OBC) department. The Data Science / IT department (DSIT) will process the frames for obeying the anonymization regulations. For key feature identification, the frames will be grouped by the OBC into the classes that represent the plane views for each trimester. DSIT will try different state-of-the-art DL pre-trained algorithms on the data set with plane views. All the recent DL entries will be tailored and tested on the current two scenarios of key view identification and semantic segmentation. Their performance results (their prediction against the ground truth marked by the OBC) will be analyzed in comparison by means of a statistical test. The accuracy-speed equilibrium will be taken into account in the ranking of the approaches, since the system will finally perform on a video. Once a new video will be available in practice, the model chosen for the respective task will highlight the key feature or the segmented region on video and also provide a degree of confidence in its recognition. The OBC physicians will validate all the intermediary findings at frame level, as well as the meaningfulness of the video labelling and segmentation. The outcomes of the model on the first and second trimester videos of the same patient will be compared to assess the discrepancy.
AI (ARTIFICIAL INTELLIGENCE) ANALYSIS
Database construction:
The data set for AI analysis will be constructed from images extracted from ultrasound scans taken in the apical plane. Consequently, a classification problem with four categories corresponding to the given key views is considered. An additional Other class is appointed and populated with images of other unimportant frames from the scan.
Image preprocessing for fetal heart scans:
The first step is represented by the extraction performed by converting the image to gray scale and applying a threshold. In this way, the background noise is discarded. In order to eliminate the small bridges between the area of interest and other areas in the image, erosion is applied using a 10x10 pixels kernel. After erosion, besides the area of interest, several smaller "islands" may appear in the image. The zone of interest has two properties that distinguish it from the rest of the islands: it always covers the central area of the image and it has the highest area. In order to eliminate the non-relevant islands, the spots that cover the central area of the image are first identified, then the spot with the highest surface coverage is selected. The detected spot is filled, then the dimension is restored by applying a dilation algorithm, using the same kernel of 10x10 pixels. In order to prevent losing the fine details around the dilated spot, its convex hull is drawn and filled. In the end, the generated spot is used as a mask to extract the area of interest from the original image.
Experimental results:
Three variants of the data collection are considered: the original double-sided (standard + Doppler) samples, the Doppler single crops and merged image pairs of resulting standard and Doppler crops.
The ResNet18 and ResNet50 architectures, with similar setups, are applied for each data set in turn for evaluating the suitability of the preliminary processing.
As the data collections with cropped images contain representatives from all the initial images, all sets thus have the same number of items and structure per each class, as well as for the training, validation and test separations. For an objective evaluation, all images that are extracted from a patient lie within the same separation of the data set, i.e. training, validation or test. This occurs even if there were multiple video files for a patient made at different moments (e.g. weeks apart) in time.
The images are resized to 224 × 224 pixels. The 1cycle policy is used and the implementation is made using fastai and PyTorch libraries. The initial model weights are taken through transfer learning, as pretrained on the ImageNet data set. The default options for data augmentations are used. There are 2 steps involved in the training process, each containing only 10 epochs. Within the first training session, all layers are frozen, except for the batch normalization layers and the head of the model. Its choice controls how the weights of the network are adjusted with respect to the loss gradient and selecting a proper value is essential for making the model converging to a local minimum, and reaching thus improved accuracy in a smaller amount of epochs. The batch size is taken equal to 32. The model that hits the highest accuracy on the validation data is applied on the test set. For each of the 2 architectures and for each separate data set, 5 repeated applications are made and the reported results for each case are computed as the average over the 5 outcomes. The runs are made in Google Colab, using Tesla T4 for GPU. B. The successful gradient class activation map (Grad-CAM) approach is used for outlining the decisions of the model for the Aorta and Other labelling for each data set. The plots are derived from the 5 runs that are computed for each distinct (architecture, data set) setup.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women in their first and second trimester | – | Diagnostic Test: Routine ultrasound examinationPregnant women in their first and second trimester will be examined using two-dimensional echocardiography of the fetal heart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All pregnant women of 18 years and above, in their first and second trimester are considered eligible for the study.
Key inclusion criteria (2 listed)
- pregnant women in their first and second trimester
- signed informed consent for the study
Key exclusion criteria (2 listed)
- unknown outcome of pregnancy
- age under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine ultrasound examinationULTRASOUND EXAMINATION Women recruited to take part in the study will undergo the routine ultrasound examinations and monitoring, including a fetal echocardiogram between 12-13+6 weeks of gestation (for the first trimester cases) and between 18-24 weeks of gestation (for the second trimester cases). Two-dimensional evaluation of each fetal heart will include a cine loop sweep obtained from the from the four-chamber view plane by moving the transducer cranially towards the upper mediastinum, allowing the visualization of the following planes: four-chamber view, left and right ventricular outflow tracts, three vessels and trachea view. The examination will be stored for further analysis. | Diagnostic test | Pregnant women in their first and second trimester |
Primary outcome
Development of an Intelligent Decision Support System for fetal echocardiography
Time frame: 24 months
The primary objective of this study is the design and development of the IS that can significantly assist the physician in the improvement of detection of fetal congenital heart disease compared to the common standard of care.
2 secondary outcomes
Counseling aid for newly trained sonographers
Time frame: 36 months
Improveing the prenatal diagnosis
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Derived from this study: PubMed 36631859Ungureanu A, Marcu AS, Patru CL, Ruican D, Nagy R, Stoean R, Stoean C, Iliescu DG. Learning deep architectures for the interpretation of first-trimester fetal echocardiography (LIFE) - a study protocol for developing an automated intelligent decision support system for early fetal echocardiography. BMC Pregnancy Childbirth. 2023 Jan 11;23(1):20. doi: 10.1186/s12884-022-05204-x.
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.
Dominic G Iliescu, Assoc. Prof. study chair
University of Medicine and Pharmacy Craiova
Anda Ungureanu, PhD(c) study director
University of Medicine and Pharmacy Craiova
Rodica Nagy, PhD(c) principal investigator
University of Medicine and Pharmacy Craiova
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 University of Medicine and Pharmacy Craiova at 1 site in Romania.
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 2 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 22 Oct 2021. 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 Romania. 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 Dominic G Iliescu, Assoc. Prof. (723888773 ext. +40, dominic.iliescu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of an Intelligent Decision Support System for fetal echocardiography (time frame: 24 months). 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 NCT05090306, which also lists 1 linked publication.
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 22 Oct 2021.