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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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

Other trials in South Korea

Austria1 site
  • Medical University of Vienna

    Vienna

Other trials in Austria

Belgium1 site
  • Université Catholique de Louvain

    Brussels

Other trials in Belgium

Germany1 site
  • University of Goettingen Medical Center

    Göttingen

Other trials in Germany

Lithuania1 site
  • Vilnius University

    Vilnius

Other trials in Lithuania

United Kingdom1 site
  • Barts Heart Centre

    London

Other trials in United Kingdom

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.

  1. 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)
  1. 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

  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 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.

  1. First posted13 Nov 2023
  2. Study start1 Jan 2020
  3. Primary completionSep 2026 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

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)
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

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.

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