Abdominal Aorta AneurismVASCUL-AID-PRONCT07187700
Developing Trustworthy Artificial Intelligence (AI)-Driven Tools to Predict Vascular Disease Risk and Progression: the Prospective VASCUL-AID Study
An observational study of Abdominal Aorta Aneurism and Peripheral Arterial Disease, run by Amsterdam UMC.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Abdominal Aorta Aneurism, Peripheral Arterial Disease
- How many people
- 1,100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Dec 2030
- How long will I take part?
- 4 Years
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Keywords
- Abdominal aortic aneurysm, peripheral arterial disease, artificial intelligence, cardiovascular risk, prediction models, disease progression
- Medical subject headings
- Peripheral Arterial Disease, Aortic Aneurysm, Abdominal, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Accuracy of developed VASCUL-AID AI-driven algorithms that classify AAA patients according to high or low risk disease progression and MACE. In addition, models will be developed on the other predefined outcomes from the core outcome set, these include: clinical success after an operation [yes/no], graft infection after an operation [yes/no], reintervention [yes/no], the AAA can be treated through endovascular treatment [yes/no], adherence to prescribed drugs [yes/no], secondary prevention, treatment options and complications.
Measured: 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.
Accuracy of developed VASCUL-AID AI-driven algorithms that classify PAD patients according to high or low risk disease progression, MALE and MACE. In addition, models will be developed on the other predefined outcomes from the core outcome set, these include: acute limb ischemia [yes/no], thromboembolic complications [yes/no], disease progression [yes/no], pain-free walking distance [meters], physical activity, smoking cessation, secondary prevention, treatment options and complications.
Measured: From baseline to 4 years follow-up
Patient reported outcome measures for AAA and PAD.
Good communication by healthcare worker about diagnosis [Questionnaires].
Measured: From baseline to 4 years follow-up.
Patient reported outcome measures for health-related quality of life.
Numeric (Pain) Rating Scale (0-10, no pain to most intense pain).
Measured: From baseline to 4 year follow-up.
Patient reported outcome measures for health-related quality of life.
PROMIS Scale v1.2 - Global Health measure. Answer rank on a scale of 0-5, with the higher score being more preferred.
Measured: From baseline to 4 year follow-up
Patient reported outcome measures for health-related quality of life.
EQ-5D-5L Euroqol questionnaire.
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: From baseline to 4 years follow-up.
Patient reported outcome measures for vascular quality of life for PAD.
Vascular Quality of Life Questionnaire (VascuQol) consists of 25 questions regarding the QoL in patients with vascular diseases, regarding activity level, symptoms, pain, emotion and social consequences. It uses a 7-point Likert scale, where a low score equels a severe sense of limitations.
Measured: From baseline to 4 year follow-up
Patient reported outcome measures for AAA related quality of life.
AneurysmDQoL - Abdominal Aortic Aneurysm Quality of Life
The AneurysmDQoL is a 24-item measure including two overview items designed for audit purposes which measure generic 'present QoL' and AAA-specific 'impact of AAA on QoL'. A further 22 items measure the impact of having an abdominal aortic aneurysm on specific aspects of life and the importance of these aspects of life for QoL. In addition the questionnaire includes a free-text item. This allows patients to comment on any other QoL domains not covered in the questionnaire.
Measured: From baseline to 4 year follow-up.
Questions regarding medical status.
A custom list of questions developed to gather all changes in medical history of the patients.
Measured: From baseline to 4 year follow-up
6-minute walking test questionnaire
The 6-minute walking test is a test in which patients are asked to walk for a duration of 6 minutes and then report the distance they have walked in that time and whether they experienced any complaints.
Measured: From baseline to 4 year follow-up
Medication use questionnaire
Asks the patient to write down all active medication.
Measured: From baseline to 4 year follow-up
Smoking cessation questionnaire
A custom list of questions asking patients about smoking cessation and how they are managing quitting.
Measured: From baseline to 4 year follow-up.
Questionnaire regarding health-care provider communication.
This questionnaire scores how well the patient experienced contact with their health care provider. Each question is answered on a scale between strongly agree - strongly disagree.
Measured: From baseline to 4 year follow-up.
Cost-effectiveness and Clinical Implementation Study
The project will include data collection of costs and Health-Related Quality of Life (HRQoL) prospectively. The economic analysis will be performed in accordance with the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. An estimation of costs and HRQoL progression until MACE will be performed and descriptive statistics will be used to describe their respective evolution (up to 4 years).
To describe the evolution and further estimate threshold where the implementation of VASCULAID within hospitals could be more efficient, the number of patients with at least one MACE during the follow-up period will be used to estimate the costs and HRQoL per event among the dedicated subgroup of population where HRQoL is collected. Only direct costs will be considered in the analysis.
The result will be expressed in euros per patient (then distinguishing MACE vs free of MACE) over the follow-up. QALYs will be expressed per patients.
Measured: baseline to 4 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aorta AneurismStudies of the same condition, open and under way.
- 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
- 1,100 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Brightfish, Technical University of Twente, Universidade do Porto, Aveiro University, Centro Hospitalar De São João, E.P.E., Stichting Allai, University of Belgrade, Hospital District of Helsinki and Uusimaa, VINČA INSTITUTE OF NUCLEAR SCIENCES Belgrado, University of Bergen, Asklepios Kliniken Hamburg GmbH, Centre Hospitalier Universitaire de Nice, University of Oxford
- Responsible party
- Principal investigator, Associate Prof. Dr. Kak Khee Yeung, Amsterdam UMC
- Investigators
- Prof. Dr. K.K. Yeung, MD, PhdD, FEBVS, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187700
- Sponsor's protocol ID
- 2025.0042
- Acronym
- VASCUL-AID-PRO
- Status last verified
- Sep 2025
- First submitted
- 13 Aug 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient data will be pseudoanonymised and recorded in an eCRF provided in the web-based app, a secured central data system conform EU GDPR guidelines hosted by Brightfish B.V. (certified: ISO 27001, NEN751-012, ISC121, ISO9001:2015; QSC808). The collected data consists of heart-rate data, blood pressure values, clinical questionnares, medical records, medical imaging, blood samples for proteomics, lipidomics and genomics analyses results, demographics.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Trustworthy Artificial Intelligence (AI)-Driven Tools to Predict Vascular Disease Risk and Progression: the Prospective VASCUL-AID Study
- ClinicalTrials.gov ID
- NCT07187700
- Acronym / sponsor ID
- VASCUL-AID-PRO / 2025.0042
- Keywords
- Abdominal aortic aneurysm, peripheral arterial disease, artificial intelligence, cardiovascular risk, prediction models, disease progression
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Amsterdam UMCUniversity, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Brightfish, Technical University of Twente, Universidade do Porto, Aveiro University, Centro Hospitalar De São João, E.P.E., Stichting Allai, University of Belgrade, Hospital District of Helsinki and Uusimaa, VINČA INSTITUTE OF NUCLEAR SCIENCES Belgrado, University of Bergen, Asklepios Kliniken Hamburg GmbH, Centre Hospitalier Universitaire de Nice, University of Oxford
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 23 Sep 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (9 listed)
- 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
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
Development and internal validation of AI-driven tools to predict high or low risk disease progression in AAA and PAD.
Time frame: From baseline to 4 years follow-up.
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.
14 secondary outcomes
Accuracy of developed VASCUL-AID driven algorithms that classify AAA patients according to high or low risk disease progression.
Time frame: 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.
Time frame: From baseline to 4 years follow-up
Patient reported outcome measures for AAA and PAD.
Time frame: From baseline to 4 years follow-up.
Patient reported outcome measures for health-related quality of life.
Time frame: From baseline to 4 year follow-up.
Patient reported outcome measures for health-related quality of life.
Time frame: From baseline to 4 year follow-up
Patient reported outcome measures for health-related quality of life.
Time frame: From baseline to 4 years follow-up.
Patient reported outcome measures for vascular quality of life for PAD.
Time frame: From baseline to 4 year follow-up
Patient reported outcome measures for AAA related quality of life.
Time frame: From baseline to 4 year follow-up.
Questions regarding medical status.
Time frame: From baseline to 4 year follow-up
6-minute walking test questionnaire
Time frame: From baseline to 4 year follow-up
Medication use questionnaire
Time frame: From baseline to 4 year follow-up
Smoking cessation questionnaire
Time frame: From baseline to 4 year follow-up.
Questionnaire regarding health-care provider communication.
Time frame: From baseline to 4 year follow-up.
Cost-effectiveness and Clinical Implementation Study
Time frame: baseline to 4 years follow-up
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 23 Sep 2025.
- The consortium website with further information regarding the incorporated studies.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient data will be pseudoanonymised and recorded in an eCRF provided in the web-based app, a secured central data system conform EU GDPR guidelines hosted by Brightfish B.V. (certified: ISO 27001, NEN751-012, ISC121, ISO9001:2015; QSC808). The collected data consists of heart-rate data, blood pressure values, clinical questionnares, medical records, medical imaging, blood samples for proteomics, lipidomics and genomics analyses results, demographics.
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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.
Prof. Dr. K.K. Yeung, MD, PhdD, FEBVS principal investigator
Amsterdam UMC
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aorta Aneurism and Peripheral Arterial Disease, run by Amsterdam UMC.
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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Tim P Crone, Master of Science (+31623324474, t.crone@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development and internal validation of AI-driven tools to predict high or low risk disease progression in AAA and PAD. (time frame: From baseline to 4 years follow-up.). 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 23 Sep 2025.