Status:
NOT_YET_RECRUITING
Developing Trustworthy Artificial Intelligence (AI)-Driven Tools to Predict Vascular Disease Risk and Progression: the Prospective VASCUL-AID Study
Lead Sponsor:
Amsterdam UMC
Collaborating Sponsors:
Amsterdam UMC, location VUmc
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Abdominal Aorta Aneurism
Peripheral Arterial Disease
Eligibility:
All Genders
40-90 years
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 PA...
Eligibility Criteria
Inclusion
- 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.
- Exclusion Criteria PAD:
- 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).
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT07187700
Start Date
September 1 2025
End Date
December 1 2030
Last Update
September 23 2025
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