Tonometry(1) and Duplex Ultrasound(2) to Predict CV Events in to be Treated Patients With an AAA

Summary

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

• Abdominal Aortic Aneurysm
• Cardiovascular Events

Interventions

DIAGNOSTIC_TEST

Carotid Artery Reactivity test (CAR test)

The CAR test will be applied to stimulate the sympathetic nervous system. This thermal stimulus is known to elevate blood pressure via sympathetic pathways, so it can be used to study the vascular response to sympathetic activation. The participant will submerge their left hand in a bucket of ice water (approximately 4 degrees celcius) for 3 minutes, which is reported to be sufficient to induce a maximal dilation in the common carotid artery. At baseline and every minute after the hand is submerged in ice water, the blood pressure will be measured to check whether a sympathetic stimulation is achieved.

DIAGNOSTIC_TEST

Arterial Stiffness

The SphygmoCor device will be used to non-invasively measure arterial stiffness parameters using applanation tonometry. For Pulse Wave Analyses (PWA), the radial waveform will be recorded. Approximately 10 waveforms are averaged, resulting in several non-invasive parameters: * Peripheral pressure parameters * Central and abdominal aneurysm pressure parameters (derived using a transfer function) * Cardiac output parameters (sub-endocardial viability ratio (SEVR), Ejection Duration (ED)) Pulse wave velocity will be performed by recording the waveforms of the carotid and femoral artery sequentially. The travelled distance will be measured according to the current guidelines and entered in the program. The program will calculate the PWV based on 10 ECG triggered waveform of each artery.

Sponsors & Collaborators

• Radboud University Medical Center

  collaborator OTHER

• Canisius-Wilhelmina Hospital

  collaborator OTHER

• Gelderse Vallei Hospital

  collaborator OTHER

• Medisch Spectrum Twente

  collaborator OTHER

• Deventer Ziekenhuis

  collaborator OTHER

• Gelre Hospitals

  collaborator OTHER

• Maxima Medical Center

  collaborator OTHER

• Rijnstate Hospital

  lead OTHER

Principal Investigators

• Michel Reijnen, MD, prof · Rijnstate Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-12

Primary Completion

2026-12-31

Completion

2027-06-30

Countries

• Netherlands

Study Locations