Tonometry(1) and Duplex Ultrasound(2) to Predict CV Events in to be Treated Patients With an AAA
Recruiting now
Conditions studied: Abdominal Aortic Aneurysm, Cardiovascular Events
In brief
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.
Key facts
- Study ID
- NCT04183426
- Run by
- Rijnstate Hospital
- People needed
- 194
- Starts
- 2020-06-12
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2025-03-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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.
Where it is running
- Radboudumc — Nijmegen, Gelderland, Netherlands (enrolling)
- Canisius Wilhelmina Ziekenhuis — Nijmegen, Gelderland, Netherlands (enrolling)
- Gelre Hospitals — Apeldoorn, Netherlands (enrolling)
- Deventer Hospital — Deventer, Netherlands (enrolling)
- Ziekenhuis Gelderse Vallei — Ede, Netherlands (enrolling)
- Medisch Spectrum Twente — Enschede, Netherlands (enrolling)
- Maxima Medical Center — Veldhoven, Netherlands (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.