Actively Recruiting

Age: 18Years +
All Genders
NCT04183426

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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