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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRijnstate Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Male or female at least 18 years old;

Informed consent form understood and signed and patient agrees to follow- up visits;

Has an infrarenal or juxtarenal abdominal aortic aneurysm (AAA), scheduled for elective repair (i.e open repair, EVAR, FEVAR and CHEVAR) according to standard practice;

Disqualifiers

Life expectancy < 2 years;

Psychiatric or other condition that may interfere with the study;

Participating in another clinical study, interfering on outcomes;

Increased risk for coronary spasms (score Rose-questionnaire ≥2;

Trial design

Treatments tested in this trial

  • Carotid Artery Reactivity test (CAR test)
  • Arterial Stiffness

Treatment groups

No treatment groups listed

Sponsors and collaborators

Rijnstate Hospital

Lead sponsor

Radboud University Medical Center

Collaborator

Canisius-Wilhelmina Hospital

Collaborator

Gelderse Vallei Hospital

Collaborator

Medisch Spectrum Twente

Collaborator

Deventer Ziekenhuis

Collaborator

Gelre Hospitals

Collaborator

Maxima Medical Center

Collaborator