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

Study acronym: One-Two-Treat
StatusRecruiting
PhaseNot specified
Started2020-06-12
View on ClinicalTrials.gov ↗

Amendment history

2025-03-03
minor
Study Status v5
Re-verified, no change to tracked fields
2023-11-15
minor
Study Status v4
Primary completion date2025-12→2026-12
Completion date2026-06→2027-06
2022-11-10
minor
Study Status, Sponsor/Collaborators, Study Description, Study Design, Contacts/Locations v3
Primary completion date2022-12→2025-12
Completion date2024-12→2026-06
Enrollment target192→194
Study sites2→7
Study descriptionrevised
The investigators will include 192194 patients with an AAA who will be scheduled for repair. Part [...] nsent. In this observational, prospective study, a total of 192194 patients who are going to be treated for their AAA will be [...]
Collaborators2 to 7 entries
Gelderse Vallei Hospital Medisch Spectrum Twente Deventer Ziekenhuis Gelre Hospitals Maxima Medical Center
2020-10-09
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-05→confirmed 2020-06-12
Study sitesdetails revised at 2 of 2 sites
2020-03-18
minor
Study Status v1
Start date2020-01→2020-05
2019-11-28
minor
Original filing
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.
Trial Details
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