Tonometry(1) and Duplex Ultrasound(2) to Predict CV Events in to be Treated Patients With an AAA

Abdominal aortic aneurysm (AAA) is a common vascular disease and associated with risk of rupture, but also with a high cardiovascular (CV) event rate. A key difficulty in AAA is predicting these life-threatening complications, which are strongly linked to vascular health. In 2013, the SMART risk score was developed to calculate the risk of the patients for recurrent vascular events based on clinical characteristics. Recently, a novel, easy to perform, non-invasive test of endothelial function (the carotid artery reactivity (CAR) test), reflecting target organ damage, has been introduced. The CAR is a simple, quick (5-min), non-invasive test that uses ultrasound to examine the carotid artery in response to sympathetic stimulation by placing one hand in cold water. This test shows strong agreement with both coronary and aortic responses to sympathetic stimulation and predicted CV-events in patients with peripheral arterial disease. The aim of this prospective 2-year follow-up study is to investigate the predictive capacity of the CAR-test for development of CV-events after elective AAA repair in comparison to the SMART risk score. Secondary objectives are to investigate the predictive capacity of arterial stiffness measurements and the post-operative CAR-test for development of CV-events and to evaluate health status scores to provide insight if these scores can support clinical decision making.

NCT Number	NCT04183426
Lead Sponsor	Rijnstate Hospital Collaborators: Radboud University Medical Center, Canisius-Wilhelmina Hospital, Gelderse Vallei Hospital, Medisch Spectrum Twente, Deventer Ziekenhuis, Gelre Hospitals, Maxima Medical Center
Conditions	Abdominal Aortic Aneurysm, Cardiovascular Events
Enrollment	194 participants
Start Date	2020-06-12
Primary Completion	2026-12 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2025-03-06