Actively Recruiting
Tonometry(1) and Duplex Ultrasound(2) to Predict CV Events in to be Treated Patients With an AAA
Led by Rijnstate Hospital · Updated on 2025-03-06
194
Participants Needed
7
Research Sites
363 weeks
Total Duration
On this page
Sponsors
R
Rijnstate Hospital
Lead Sponsor
R
Radboud University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tonometry(1) and Duplex Ultrasound(2) to Predict CV Events in to be Treated Patients With an AAA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female at least 18 years old
- Signed informed consent and agreement to follow-up visits
- Diagnosed with infrarenal or juxtarenal abdominal aortic aneurysm scheduled for elective repair (open repair, EVAR, FEVAR, or CHEVAR) according to standard practice
You will not qualify if you...
- Life expectancy less than 2 years
- Psychiatric or other conditions that may interfere with participation
- Currently participating in another clinical study affecting outcomes
- Increased risk for coronary spasms (Rose questionnaire score 2 or higher)
- Presence of Raynaud's phenomenon, Marfan syndrome, chronic pain syndrome in upper limbs, AV fistula or shunt, open wounds on upper limbs, or scleroderma
- Recent (within 3 months) angina pectoris, myocardial infarction, cerebral infarction, heart failure, or peripheral artery disease treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525GA
Actively Recruiting
2
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, Netherlands, 6532SZ
Actively Recruiting
3
Gelre Hospitals
Apeldoorn, Netherlands
Actively Recruiting
4
Deventer Hospital
Deventer, Netherlands
Actively Recruiting
5
Ziekenhuis Gelderse Vallei
Ede, Netherlands
Actively Recruiting
6
Medisch Spectrum Twente
Enschede, Netherlands
Actively Recruiting
7
Maxima Medical Center
Veldhoven, Netherlands
Actively Recruiting
Research Team
M
Michel Reijnen, MD, prof
CONTACT
J
Jenske Vermeulen, MSc.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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