Aortic StenosisNCT06128876
CMR-AI and Outcomes in AS
An observational study of Aortic Stenosis, run by Medical University of Vienna at 7 sites in 6 countries.
Trial summary
Background \& Aims: Artificial Intelligence (AI) in cardiac magnetic resonance (CMR) imaging has previously been shown to provide highly reproducible and accurate measures of myocardial structure and function, outperforming clinical experts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- How many people
- 1,500 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 1 Jan 2020to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe degenerative AS scheduled for valvular treatment undergoing pre-procedural CMR imaging were previously enrolled from seven university-affiliated tertiary care centers in Continental Europe, the UK, and Asia between January 2020 and August 2024.
Who may be able to join
- Written informed consent
- Severe AS scheduled for Heart Team decision
Who cannot join
- Inability or unwillingness to perform any of the diagnostic tests
- Inability or unwillingness to participate in follow-up visits
- Metal implants, e.g. cochlear implants and pacemakers
- Chronic kidney failure (GFR < 30 ml/min/1.73m2)
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
South Korea2 sites
Samsung Medical Center
Seoul
Seoul National University College
Seoul
About this study
Official title: Artificial Intelligence-based Risk Stratification and Mid-term Outcomes in Severe Aortic Stenosis: Insights from Cardiac Magnetic Resonance Imaging
Background \& Aims: Artificial Intelligence (AI) in cardiac magnetic resonance (CMR) imaging has previously been shown to provide highly reproducible and accurate measures of myocardial structure and function, outperforming clinical experts. The prognostic value of more sensitive markers of early left (LV) and right ventricular (RV) function, such as global longitudinal shortening (GLS), mitral annular plane systolic excursion (MAPSE), and tricuspid annular plane systolic excursion (TAPSE) has not been established due to the lack of automated analysis. Thus, our aim is to evaluate whether AI-based measurements of these early markers of adverse cardiac remodeling convey relevant prognostic information in patients with severe aortic stenosis (AS) beyond LV and RV ejection fraction (EF).
Materials \& Methods: In a current large-scale international, prospective, multi-center study ~1500 patients with severe AS underwent CMR imaging prior to aortic valve replacement (AVR). An AI-based algorithm, developed in the UK, was used for fully automated assessment of parameters of cardiac structure (end-diastolic volume, end-systolic volume, LV mass, maximum wall thickness) and function (EF, GLS, MAPSE, TAPSE). In this proposed follow-up project, we aim to associate these AI-based CMR parameters at baseline with mid-term clinical outcomes at 24-months post-AVR. A composite of all-cause mortality and heart failure hospitalization will serve as the primary endpoint. CMR-AI will be repeated at 24-months follow-up and trajectories from pre- to post-AVR will be assessed as a secondary endpoint.
Future Outlook: In severe AS, a novel AI-based algorithm allows immediate and precise measurements of ventricular structure and function on CMR imaging. Our goal is to identify early markers of cardiac dysfunction indicating adverse mid-term prognosis post-AVR. This has guideline-forming potential as the optimal timepoint for AVR in patients with AS is currently a matter of debate.
Read the detailed description
Artificial Intelligence (AI) and Machine Learning are reshaping our daily clinical practice, which has the potential to be more efficient, precise, and personalized. Adopting these technologies in cardiac imaging does not only affect decision making by improved accuracy and risk stratification but also significantly reduces scan times and post-imaging workup.
Current guidelines acknowledge cardiac magnetic resonance (CMR) imaging as gold standard for assessment of myocardial structure and function. Despite the fundamental importance in various cardiac diseases, measurements of size, mass, and ejection fraction (EF) are flawed by the inherent variability and subjectivity of human analysis. Recent developments in deep learning using convolutional neural networks (CNNs) allow for automated segmentation of the ventricular blood pool and myocardium using pre-existing CMR datasets. Importantly, these tools are integrated into CMR scanners generating real-time measurements without the need of time-consuming image post-processing. AI-based models have previously shown similar to superior precision in ventricular contouring, volumetry, and maximum wall thickness (MWT) measurements, outperforming clinical experts.
In patients with aortic stenosis (AS), changes in EF more often occur late in the disease process, whereas longitudinal shortening represents an earlier and more sensitive marker of left ventricular (LV) dysfunction. However, these CMR measurements are subjective, time-consuming, and therefore not routinely performed due to the lack of automated analysis. Recently, AI-measured global longitudinal shortening (GLS) and mitral annular plane systolic excursion (MAPSE) have been demonstrated to provide more reproducible and accurate results compared to human experts. We hypothesize that AI-based GLS and MAPSE could convey important prognostic information beyond LVEF in severe AS and represent early markers of adverse cardiac remodeling and outcome following aortic valve replacement (AVR). Furthermore, in our own working group, we could demonstrate that right ventricular (RV) dysfunction on CMR, rather than conventional parameters assessed by echocardiography, was independently associated with outcome in individuals with AS undergoing transcatheter aortic valve implantation. We aim to extend on our findings and investigate whether AI-based RV GLS and tricuspid annular plane systolic excursion (TAPSE) represent early markers of RV dysfunction indicating adverse prognosis.
Finally, the assessment of reverse cardiac remodeling by CMR requires reproducibility. AI has been proven to outperform humans in both precision and accuracy, and therefore has great potential for the comprehensive evaluation of longitudinal structural changes in AS following AVR. We aim to analyze mid-term reverse cardiac remodeling in patients with AS using novel AI technology.
Aims
With significant previous contributions in cardiac imaging and valvular heart disease being made by our research group, we aim to provide automated, precise, and time-saving algorithms to identify patients at risk post-AVR by addressing the following:
- Association of AI-measured LV and RV structural and functional markers on CMR prior to AVR with mid-term clinical outcomes at 24-months following AVR.
- Reverse cardiac remodeling, as determined by CMR-AI parameters, at baseline versus 24-months after AVR.
Methods
This project is designed as a large-scale international, prospective, multi-center, longitudinal-observational cohort study aimed at identifying predictors of structural and functional recovery in patients with severe AS undergoing clinically indicated AVR. Participants were previously enrolled from seven university-affiliated tertiary care centers in Continental Europe, the UK, and Asia between January 2020 and August 2024.
Baseline evaluation consisted of comprehensive pre-operative cardiac phenotyping including quality of life assessment, blood tests, electrocardiogram (ECG), and imaging (CMR and echocardiography). For this proposed project, reverse cardiac remodeling and mid-term clinical outcomes will be evaluated 24-months post-AVR through repeat baseline investigations.
- Conditions
- Aortic Stenosis
- Keywords
- Aortic Stenosis, Artificial Intelligence, Cardiac Magnetic Resonance, Imaging, Outcomes
- Medical subject headings
- Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with AI-measured parameters of impaired left and right ventricular structure and function on cardiac magnetic resonance imaging and association with the composite of all-cause death and heart failure hospitalization.
Association of AI-based parameters (end-diastolic volume [ml], end-systolic volume [ml], left ventricular mass [gram], maximum wall thickness [mm], ejection fraction [%], global longitudinal shortening [%], mitral/tricuspid annular plane systolic excursion [mm]) on cardiac magnetic resonance imaging with the composite of all-cause death and heart failure hospitalization.
Captured clinical endpoints will include all-cause death, cardiovascular mortality, and heart failure hospitalization. Data will be ascertained by follow-up visits, state-wide electronic hospital charts, and phone calls. In addition, mortality data will be obtained via National Death Registries of the participating countries.
Measured: 2 years
Secondary outcomes (2)
Number of patients with AI-measured parameters of impaired left and right ventricular structure and function on cardiac magnetic resonance imaging and association with components of the primary endpoint analyzed individually.
Association of AI-based parameters (end-diastolic volume [ml], end-systolic volume [ml], left ventricular mass [gram], maximum wall thickness [mm], ejection fraction [%], global longitudinal shortening [%], mitral/tricuspid annular plane systolic excursion [mm]) on cardiac magnetic resonance imaging with components of the primary endpoint (all-cause death and heart failure hospitalization) analyzed individually.
Captured clinical endpoints will include all-cause death, cardiovascular mortality, and heart failure hospitalization. Data will be ascertained by follow-up visits, state-wide electronic hospital charts, and phone calls. In addition, mortality data will be obtained via National Death Registries of the participating countries.
Measured: 2 years
Number of patients with AI-measured parameters of impaired left and right ventricular structure and function on cardiac magnetic resonance imaging and association with cardiovascular mortality.
Association of AI-based parameters (end-diastolic volume [ml], end-systolic volume [ml], left ventricular mass [gram], maximum wall thickness [mm], ejection fraction [%], global longitudinal shortening [%], mitral/tricuspid annular plane systolic excursion [mm]) on cardiac magnetic resonance imaging with cardiovascular mortality.
Captured clinical endpoints will include all-cause death, cardiovascular mortality, and heart failure hospitalization. Data will be ascertained by follow-up visits, state-wide electronic hospital charts, and phone calls. In addition, mortality data will be obtained via National Death Registries of the participating countries.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Jan 2020
- Primary completionSep 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Matthias Koschutnik, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128876
- Sponsor's protocol ID
- VIE_CMR-AI
- Status last verified
- Nov 2024
- First submitted
- 26 Oct 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-based Risk Stratification and Mid-term Outcomes in Severe Aortic Stenosis: Insights from Cardiac Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT06128876
- Acronym / sponsor ID
- VIE_CMR-AI
- Conditions
- Aortic Stenosis
- Keywords
- Aortic Stenosis, Artificial Intelligence, Cardiac Magnetic Resonance, Imaging, Outcomes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 13 Nov 2023 (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.
Background \& Aims: Artificial Intelligence (AI) in cardiac magnetic resonance (CMR) imaging has previously been shown to provide highly reproducible and accurate measures of myocardial structure and function, outperforming clinical experts. The prognostic value of more sensitive markers of early left (LV) and right ventricular (RV) function, such as global longitudinal shortening (GLS), mitral annular plane systolic excursion (MAPSE), and tricuspid annular plane systolic excursion (TAPSE) has not been established due to the lack of automated analysis. Thus, our aim is to evaluate whether AI-based measurements of these early markers of adverse cardiac remodeling convey relevant prognostic information in patients with severe aortic stenosis (AS) beyond LV and RV ejection fraction (EF).
Materials \& Methods: In a current large-scale international, prospective, multi-center study ~1500 patients with severe AS underwent CMR imaging prior to aortic valve replacement (AVR). An AI-based algorithm, developed in the UK, was used for fully automated assessment of parameters of cardiac structure (end-diastolic volume, end-systolic volume, LV mass, maximum wall thickness) and function (EF, GLS, MAPSE, TAPSE). In this proposed follow-up project, we aim to associate these AI-based CMR parameters at baseline with mid-term clinical outcomes at 24-months post-AVR. A composite of all-cause mortality and heart failure hospitalization will serve as the primary endpoint. CMR-AI will be repeated at 24-months follow-up and trajectories from pre- to post-AVR will be assessed as a secondary endpoint.
Future Outlook: In severe AS, a novel AI-based algorithm allows immediate and precise measurements of ventricular structure and function on CMR imaging. Our goal is to identify early markers of cardiac dysfunction indicating adverse mid-term prognosis post-AVR. This has guideline-forming potential as the optimal timepoint for AVR in patients with AS is currently a matter of debate.
Detailed description
Artificial Intelligence (AI) and Machine Learning are reshaping our daily clinical practice, which has the potential to be more efficient, precise, and personalized. Adopting these technologies in cardiac imaging does not only affect decision making by improved accuracy and risk stratification but also significantly reduces scan times and post-imaging workup.
Current guidelines acknowledge cardiac magnetic resonance (CMR) imaging as gold standard for assessment of myocardial structure and function. Despite the fundamental importance in various cardiac diseases, measurements of size, mass, and ejection fraction (EF) are flawed by the inherent variability and subjectivity of human analysis. Recent developments in deep learning using convolutional neural networks (CNNs) allow for automated segmentation of the ventricular blood pool and myocardium using pre-existing CMR datasets. Importantly, these tools are integrated into CMR scanners generating real-time measurements without the need of time-consuming image post-processing. AI-based models have previously shown similar to superior precision in ventricular contouring, volumetry, and maximum wall thickness (MWT) measurements, outperforming clinical experts.
In patients with aortic stenosis (AS), changes in EF more often occur late in the disease process, whereas longitudinal shortening represents an earlier and more sensitive marker of left ventricular (LV) dysfunction. However, these CMR measurements are subjective, time-consuming, and therefore not routinely performed due to the lack of automated analysis. Recently, AI-measured global longitudinal shortening (GLS) and mitral annular plane systolic excursion (MAPSE) have been demonstrated to provide more reproducible and accurate results compared to human experts. We hypothesize that AI-based GLS and MAPSE could convey important prognostic information beyond LVEF in severe AS and represent early markers of adverse cardiac remodeling and outcome following aortic valve replacement (AVR). Furthermore, in our own working group, we could demonstrate that right ventricular (RV) dysfunction on CMR, rather than conventional parameters assessed by echocardiography, was independently associated with outcome in individuals with AS undergoing transcatheter aortic valve implantation. We aim to extend on our findings and investigate whether AI-based RV GLS and tricuspid annular plane systolic excursion (TAPSE) represent early markers of RV dysfunction indicating adverse prognosis.
Finally, the assessment of reverse cardiac remodeling by CMR requires reproducibility. AI has been proven to outperform humans in both precision and accuracy, and therefore has great potential for the comprehensive evaluation of longitudinal structural changes in AS following AVR. We aim to analyze mid-term reverse cardiac remodeling in patients with AS using novel AI technology.
Aims
With significant previous contributions in cardiac imaging and valvular heart disease being made by our research group, we aim to provide automated, precise, and time-saving algorithms to identify patients at risk post-AVR by addressing the following:
- Association of AI-measured LV and RV structural and functional markers on CMR prior to AVR with mid-term clinical outcomes at 24-months following AVR.
- Reverse cardiac remodeling, as determined by CMR-AI parameters, at baseline versus 24-months after AVR.
Methods
This project is designed as a large-scale international, prospective, multi-center, longitudinal-observational cohort study aimed at identifying predictors of structural and functional recovery in patients with severe AS undergoing clinically indicated AVR. Participants were previously enrolled from seven university-affiliated tertiary care centers in Continental Europe, the UK, and Asia between January 2020 and August 2024.
Baseline evaluation consisted of comprehensive pre-operative cardiac phenotyping including quality of life assessment, blood tests, electrocardiogram (ECG), and imaging (CMR and echocardiography). For this proposed project, reverse cardiac remodeling and mid-term clinical outcomes will be evaluated 24-months post-AVR through repeat baseline investigations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe degenerative AS scheduled for valvular treatment undergoing pre-procedural CMR imaging were previously enrolled from seven university-affiliated tertiary care centers in Continental Europe, the UK, and Asia between January 2020 and August 2024.
Key inclusion criteria (2 listed)
- Written informed consent
- Severe AS scheduled for Heart Team decision
Key exclusion criteria (4 listed)
- Inability or unwillingness to perform any of the diagnostic tests
- Inability or unwillingness to participate in follow-up visits
- Metal implants, e.g. cochlear implants and pacemakers
- Chronic kidney failure (GFR < 30 ml/min/1.73m2)
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
Number of patients with AI-measured parameters of impaired left and right ventricular structure and function on cardiac magnetic resonance imaging and association with the composite of all-cause death and heart failure hospitalization.
Time frame: 2 years
Association of AI-based parameters (end-diastolic volume [ml], end-systolic volume [ml], left ventricular mass [gram], maximum wall thickness [mm], ejection fraction [%], global longitudinal shortening [%], mitral/tricuspid annular plane systolic excursion [mm]) on cardiac magnetic resonance imaging with the composite of all-cause death and heart failure hospitalization. Captured clinical endpoints will include all-cause death, cardiovascular mortality, and heart failure hospitalization. Data will be ascertained by follow-up visits, state-wide electronic hospital charts, and phone calls. In addition, mortality data will be obtained via National Death Registries of the participating countries.
2 secondary outcomes
Number of patients with AI-measured parameters of impaired left and right ventricular structure and function on cardiac magnetic resonance imaging and association with components of the primary endpoint analyzed individually.
Time frame: 2 years
Number of patients with AI-measured parameters of impaired left and right ventricular structure and function on cardiac magnetic resonance imaging and association with cardiovascular mortality.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
Related trials for Aortic Stenosis
Not yet recruiting
Effect of Double-Tap Optimization on Valve Expansion and Hemodynamics in Balloon-expandable Transcatheter Aortic Valve Implantation: A Randomized Clinical Trial (DO-OPT TAVI Trial)
Severe Aortic Stenosis
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruiting
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Valvular Heart Disease Patients, Aortic Stenosis
Active, not recruiting
Target Value Study to Evaluate the Safety and Efficacy of the Taurus NXT® Transcatheter Aortic Valve System for the Treatment of Severe Calcific Aortic Stenosis
Aortic Stenosis
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.
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by Medical University of Vienna at 7 sites in 6 countries.
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 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: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea, Austria, Belgium, Germany, Lithuania and 1 more country. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of patients with AI-measured parameters of impaired left and right ventricular structure and function on cardiac magnetic resonance imaging and association with the composite of all-cause death and heart failure hospitalization. (time frame: 2 years). 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 4 Dec 2024.