Using non-invasive tests to predict cardiovascular events in patients with abdominal aortic aneurysm

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to include 194 patients with abdominal aortic aneurysm (AAA) who are scheduled for repair. Participants will undergo a series of assessments, including the Carotid Artery Reactivity (CAR) test and arterial stiffness measurements, alongside traditional evaluations of AAA diameter progression. Patients will also complete questionnaires regarding their quality of life and disease experience at multiple time points over a two-year follow-up. The goal is to determine the predictive ability of these non-invasive tests for major adverse cardiovascular events (MACE).

Why it matters

Who can join: the full rules

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.

Where it's running

• Radboudumc
  Nijmegen, Gelderland, Netherlands Recruiting
• Canisius Wilhelmina Ziekenhuis
  Nijmegen, Gelderland, Netherlands Recruiting
• Gelre Hospitals
  Apeldoorn, Netherlands Recruiting
• Deventer Hospital
  Deventer, Netherlands Recruiting
• Ziekenhuis Gelderse Vallei
  Ede, Netherlands Recruiting
• Medisch Spectrum Twente
  Enschede, Netherlands Recruiting

Study contacts

• Principal investigator: Michel Reijnen, MD, prof — Rijnstate Hospital
• Study coordinator: Michel Reijnen, MD, prof
• Email: MReijnen@rijnstate.nl
• Phone: 0880057282

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.