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

Recruitingn/aAges 18 Years - anyAllRijnstate Hospital
NCT04183426 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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; Exclusion Criteria: * 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; * Presence of Raynaud's phenomenon, Marfan syndrome, chronic pain syndrome at upper extremity(s), presence of an AV fistula or shunt, open wounds to the upper extremity(s), and/or scleroderma associated with placing the hand in ice water; * Recent (\<3 months) presence of angina pectoris, myocardial infarction, cerebral infarction, and/or heart failure, or PAD treatment.
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What it tests

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

7 sites
Radboudumc
Nijmegen, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Gelre Hospitals
Apeldoorn, Netherlands
Deventer Hospital
Deventer, Netherlands
Ziekenhuis Gelderse Vallei
Ede, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Maxima Medical Center
Veldhoven, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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