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NCT Number: NCT06206369

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

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).

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital District of Helsinki and Uusimaa (HUS), Helsinki, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention, retrospective study

Other

No intervention, retrospective study

Primary outcomes

  1. Development of disease progression prediction algorithms

    Time frame: 3 years

    The 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 outcomes

  1. Internal validation of disease progression prediction algorithms

    Time frame: 3 years

    The secondary objective will be the internal validation of the developed algorithms using data from retrospective cohorts.

Study contacts

Contact information is provided by the study sponsor or research team.

Kak Khee Yeung, MD, PhD

CONTACT

[email protected]

+31 6 14278725

Lotte Rijken, Msc.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Collaborators

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

Registry information

Acronym: VASCULAIDRETRO

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Jan 16, 2024
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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