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

Tonometry(1) and Duplex Ultrasound(2) to Predict Cardiovascular Events in to be Treated Patients With an Abdominal Aortic Aneurysm (One-Two-Treat Trial)

This study is trying to see if non-invasive tests can help predict serious heart problems in patients with abdominal aortic aneurysm who are getting treatment.

Quick facts

• Study type: Observational
• Enrollment: 194 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rijnstate Hospital (Academic / other)
• Locations: 7 sites (Nijmegen, Gelderland and 6 other locations)
• Trial ID: NCT04183426 on ClinicalTrials.gov

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).

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with an infrarenal or juxtarenal abdominal aortic aneurysm scheduled for elective repair.

Not a fit: Patients with a life expectancy of less than two years or those with conditions that may interfere with the study will not benefit.

Why it matters

Potential benefit: If successful, this study could improve the ability to predict cardiovascular events in AAA patients, potentially leading to better management and outcomes.

How similar studies have performed: Other studies have shown promise in using non-invasive tests to predict cardiovascular events, but this specific approach is novel.

Eligibility criteria

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 this trial is running

Nijmegen, Gelderland and 6 other locations

• 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)
• Maxima Medical Center — Veldhoven, Netherlands (Recruiting)

Study contacts

• Principal investigator: Michel Reijnen, MD, prof — Rijnstate Hospital
• Study coordinator: Michel Reijnen, MD, prof

Conditions Abdominal Aortic Aneurysm; Cardiovascular Events; Functional Response