Abdominal Aorta Aneurism, Peripheral Arterial Disease
Conditions
Keywords
Abdominal aortic aneurysm, peripheral arterial disease, artificial intelligence, cardiovascular risk, prediction models, disease progression
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.
Interventions
None listed
Sponsors
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
Amsterdam UMC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
AAA: 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 Inclusion Criteria 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development and internal validation of AI-driven tools to predict high or low risk disease progression in AAA and PAD. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Patient reported outcome measures for AAA and PAD. | From baseline to 4 years follow-up. | Good communication by healthcare worker about diagnosis \[Questionnaires\]. |
| Patient reported outcome measures for health-related quality of life. | From baseline to 4 year follow-up. | Numeric (Pain) Rating Scale (0-10, no pain to most intense pain). |
| Patient reported outcome measures for vascular quality of life for PAD. | From baseline to 4 year follow-up | 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. |
| Patient reported outcome measures for AAA related quality of life. | From baseline to 4 year follow-up. | 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. |
| 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 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. |
| 6-minute walking test questionnaire | From baseline to 4 year follow-up | 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. |
| Medication use questionnaire | From baseline to 4 year follow-up | Asks the patient to write down all active medication. |
| Smoking cessation questionnaire | From baseline to 4 year follow-up. | A custom list of questions asking patients about smoking cessation and how they are managing quitting. |
| Questionnaire regarding health-care provider communication. | From baseline to 4 year follow-up. | 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. |
| Cost-effectiveness and Clinical Implementation Study | baseline to 4 years follow-up | 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. |
| Questions regarding medical status. | From baseline to 4 year follow-up | A custom list of questions developed to gather all changes in medical history of the patients. |
Contacts
Primary ContactTim P Crone, Master of Science
Backup ContactLuc D Busé, Bachelor of Science
Outcome results
None listed