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Developing Trustworthy Artificial Intelligence (AI)-Driven Tools to Predict Vascular Disease Risk and Progression

Developing Trustworthy Artificial Intelligence (AI)-Driven Tools to Predict Vascular Disease Risk and Progression

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06206369
Acronym
VASCULAIDRETRO
Enrollment
11000
Registered
2024-01-16
Start date
2023-10-31
Completion date
2029-05-01
Last updated
2024-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysm Abdominal, Peripheral Arterial Disease

Keywords

Artificial Intelligence, Prediction models, Image analysis, Abdominal Aortic Aneurysms, Peripheral Arterial Disease

Brief summary

The VASCULAID-RETRO study, within the broader VASCULAID project, aims to create artificial intelligence (AI) algorithms that can predict cardiovascular events and the progression of abdominal aortic aneurysm (AAA) and peripheral arterial disease (PAD). The study plans to gather and analyze data from at least 5000 AAA and 6000 PAD patients, combining existing cohorts and retrospectively collected data. During this project, AI tools will be developed to perform automatic anatomical segmentation and analyses on multimodal imaging. AI prediction algorithms will be developed based on multisource data (imaging, medical history, -omics).

Detailed description

To date, it is unknown which abdominal aortic aneurysm (AAA) and peripheral arterial disease (PAD) patients will suffer cardiovascular events or in which patients the AAA or PAD will progress. In the VASCULAID project, the VASCULAID-RETRO study aims to leverage data from existing cohorts and retrospectively collected data to develop artificial intelligence (AI) algorithms able to evaluate the risk of cardiovascular events and extent of disease progression. In order to build and train the algorithms for the predictions, we plan to retrospectively enroll at least 5000 AAA and 6000 PAD patients AI-tools will be applied to the patient data. Automatic anatomical segmentation on images and image analysis on US, CTA and MRI will be performed. Also, algorithms to predict cardiovascular events and AAA or PAD progression based on multi-source data analysis will be developed. Patient data from European clinical consortium partners is available. This consortium has access to big cohorts with relevant data for the envisioned study that will be used to enrich the existing registries. These data will be used to refine the algorithms developed for the prediction of cardiovascular events and AAA/PAD progression.

Interventions

OTHERNo intervention, retrospective study

No intervention, retrospective study

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
CollaboratorOTHER
Technical University of Twente
CollaboratorOTHER
Universidade do Porto
CollaboratorOTHER
Centre Hospitalier Universitaire de Nice
CollaboratorOTHER
Stichting Allai
CollaboratorUNKNOWN
University of Belgrade
CollaboratorOTHER
Brightfish Be
CollaboratorUNKNOWN
Hospital District of Helsinki and Uusimaa
CollaboratorOTHER
University of Bergen
CollaboratorOTHER
Asklepios Kliniken Hamburg GmbH
CollaboratorOTHER
University of Oxford
CollaboratorOTHER
VINČA INSTITUTE OF NUCLEAR SCIENCES Belgrado
CollaboratorUNKNOWN
Amsterdam UMC, location VUmc
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Males and females, 40-90 years old, with an AAA \>3cm. This includes patients with infrarenal, juxtarenal, suprarenal, iliac (defined as 1.5x its normal diameter) aneurysms, as well as mycotic aneurysms. Patients that have had interventions or ruptures will also be included * Males and females, 40-90 years old, all PAD patients (Fontaine stages 1,2,3, and 4).

Exclusion criteria

* Patients with an ascending, thoracic, thoracoabdominal (type 1-3) aneurysm.

Design outcomes

Primary

MeasureTime frameDescription
Development of disease progression prediction algorithms3 yearsThe primary goal of this retrospective study is to develop and train algorithms to predict disease progression and risk of cardiovascular events in AAA and PAD patients by leveraging multi-parametric data from 5000 AAA (\>1000 in AUMC) and 6000 PAD (\>1000 in AUMC) patients from existing cohorts and biobanks.

Secondary

MeasureTime frameDescription
Internal validation of disease progression prediction algorithms3 yearsThe secondary objective will be the internal validation of the developed algorithms using data from retrospective cohorts.

Countries

Finland, Germany, Netherlands, Portugal, Serbia, United Kingdom

Contacts

Primary ContactKak Khee Yeung, MD, PhD
k.yeung@amsterdamumc.nl+31 6 14278725
Backup ContactLotte Rijken, Msc.
l.rijken@amsterdamumc.nl

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026