Developing Trustworthy Artificial Intelligence (AI)-Driven Tools to Predict Vascular Disease Risk and Progression: the Prospective VASCUL-AID Study

NCT07187700 | Not Yet Recruiting

• 1 other identifier: 2025.0042
• Study Type: observational
• Target: 1,100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: Peripheral arterial disease (PAD) and abdominal aortic aneurysm (AAA) are vascular conditions associated with significant morbidity and mortality, with 25% of AAA patients and 23% of PAD patients being at a high risk of developing cardiovascular disease. Cardiovascular risk management can reduce the risk of major adverse cardiovascular events in AAA patients from 43% to 14%. However, cardiovascular risk is not always adequately addressed in these patients. The VASCUL-AID-PRO study aims to deliver clinically relevant prediction models using artificial intelligence and machine learning of patient outcomes to enable personalized management of vascular disease. Method: VASCUL-AID-PRO is a multi-centre international prospective cross-sectional study aiming to include 500 AAA patients and 600 PAD patients across 6 European centres. The aim is to achieve a follow-up time up to 4 years. The study will include individuals aged 40-90 with either an abdominal aortic aneurysm (infrarenal, juxtarenal, pararenal, or suprarenal abdominal aortic aneurysm) or Fontaine stage 2 peripheral arterial disease. The VASCUL-AID-PRO study will gather a variety of data from all participants, including clinical data, blood and tissue samples, cardiovascular lab values, imaging data, electrocardiograms, data from wearables and quality of life. This data gathered will be used to further develop the multi model prediction models being developed on 5000 AAA and 6000 PAD patients included in the currently ongoing VASCUL-AID-RETRO study, with the aim of providing a clinically relevant prediction models of disease progression and other cardiovascular disease for AAA and PAD patients. Furthermore, the models developed in the VASCUL-AID studies will be internally validated using a subset of patients from the VASCUL-AID-PRO study. Ethical considerations: Ethical and legal considerations are paramount throughout the VASCUL-AID project. To address these concerns, an ELSI framework will be developed and integrated into all stages of the project. This framework will be continuously updated to ensure alignment with evolving ethical, legal, and social standards. This framework will specifically focus on patient safety, data handling, AI regulation and implementation, and potential biases associated with AI.

Conditions

Abdominal Aorta Aneurism; Peripheral Arterial Disease

Keywords

Abdominal aortic aneurysm; peripheral arterial disease; artificial intelligence; cardiovascular risk; prediction models; disease progression

Outcome Measures

Primary Outcomes (1)

• Development and internal validation of AI-driven tools to predict high or low risk disease progression in AAA and PAD.

  The VASCUL-AID AI tools aim to predict AAA (rupture, mortality, cerebrovascular accident) and PAD (mortality, myocardial infarction, major amputation) progression, MACE and MALE. The internal validation is done by comparing the predicted disease progression, MACE, MALE and mortality rates with actual disease progression.

  From baseline to 4 years follow-up.

Secondary Outcomes (14)

• Accuracy of developed VASCUL-AID driven algorithms that classify AAA patients according to high or low risk disease progression.

  From baseline to 4 years follow-up

• Accuracy of developed VASCUL-AID driven algorithms that classify PAD patients according to high or low risk disease progression.

  From baseline to 4 years follow-up

• Patient reported outcome measures for AAA and PAD.

  From baseline to 4 years follow-up.

• Patient reported outcome measures for health-related quality of life.

  From baseline to 4 year follow-up.

• Patient reported outcome measures for health-related quality of life.

  From baseline to 4 year follow-up

Study Arms (2)

AAA

* Males/females between 40 and 90 years of age. * Males and females with AAA at inclusion, any diameter \>3 cm (or 1.5x larger than their non-dilated part of the aorta). * Include: infrarenal, juxtarenal, pararenal, suprarenal abdominal aortic aneurysms. Without prior AAA surgery or or planned AAA surgery within 6 months after inclusion.

PAD

* Males/females between 40 and 90 years of age. * Patients with peripheral arterial disease stage Fontaine 2a and 2b at inclusion. Medical history (e.g. CLTI) does not matter, current disease stage is leading at inclusion.

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 100 AAA patients and 100 PAD will be included per clinical center, with exeption for Asklepios Hamburg, they will solely include 100 PAD patients. This comes to a total of 1100 patients across 6 clinical centers in Europe.

You may qualify if:

• Males/females between 40 and 90 years of age.
• Include: infrarenal, juxtarenal, pararenal, suprarenal abdominal aortic aneurysms.

You may not qualify if:

• Patients with:
• Insufficient schooling or sensorial deficits that interfere understanding informed consent.
• Not able to use the VASCUL-AID mobile health app (that will be provided in Dutch, English, German, Portuguese, Serbian, Finish, Swedish languages).
• Proven or highly suspected for infected, mycotic AAA
• Previous AAA surgery or planned for an AAA surgery within 6 months
• Ruptured AAA
• Males/females between 40 and 90 years of age.
• Patients with:
• Insufficient schooling or sensorial deficits that interfere understanding informed consent.
• Not able to use the VASCUL-AID mobile health app (provided in Dutch, English, German, Portuguese, Serbian, Finnish, Swedish languages).

Sponsors & Collaborators

• Amsterdam UMC: lead
• Amsterdam UMC, location VUmc: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• Brightfish: collaborator
• Technical University of Twente: collaborator
• Universidade do Porto: collaborator
• Aveiro University: collaborator
• Centro Hospitalar De São João, E.P.E.: collaborator
• Stichting Allai: collaborator
• University of Belgrade: collaborator
• Hospital District of Helsinki and Uusimaa: collaborator
• VINČA INSTITUTE OF NUCLEAR SCIENCES Belgrado: collaborator
• University of Bergen: collaborator
• Asklepios Kliniken Hamburg GmbH: collaborator
• Centre Hospitalier Universitaire de Nice: collaborator
• University of Oxford: collaborator

Related Links

• The consortium website with further information regarding the incorporated studies.

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, blood plasma, aorta tissue

MeSH Terms

Conditions

Peripheral Arterial Disease; Aortic Aneurysm, Abdominal; Disease Progression

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Aortic Aneurysm; Aneurysm; Aortic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof. Dr. K.K. Yeung, MD, PhdD, FEBVS

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tim P Crone, Master of Science

CONTACT

+31623324474; t.crone@amsterdamumc.nl

Luc D Busé, Bachelor of Science

CONTACT

+31637143811; l.buse@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: September 23, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data sharing agreement was signed by all parties in August 2024 and shall remain in force for the period of the Project, unless terminated earlier
• Access Criteria: All partners in the VASCUL-AID consortium through the Brightfish system and through XNAT for medical imaging.