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.
The investigators will include 194 patients with an AAA who will be scheduled for repair. Participants will be recruited from all collaborating hospitals (currently Radboudumc, Rijnstate, CWZ) after providing written informed consent. In this observational, prospective study, a total of 194 patients who are going to be treated for their AAA will be included. Baseline patient characteristics will be registered, including traditional risk factors and CV-history. In addition to regular care of measuring AAA diameter progression (in mm/year), we will perform the CAR-test (10-min) and non-invasive arterial stiffness measures (PWA and PWV) with the SphygmoCor device (10-min). Furthermore, the investigators will ask patients to complete a questionnaire about the quality of their life. A second questionnaire tries to clarify the disease experience of the patients. Both questionnaires will be asked to be completed at the start, 6-8 weeks after repair, after one year and after two years of repair. Subsequently, the investigators will record major adverse cardiovascular events (MACE) according to the International Classification of Disease-10. Registration of MACE will be performed using hospital-records and following international guidelines. Across a 2-year follow-up, by means of regular follow-up appointments, the investigators will examine the ability of the CAR parameter and arterial stiffness parameters to predict CV-events.
Study Type
OBSERVATIONAL
Enrollment
194
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.
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.
Radboudumc
Nijmegen, Gelderland, Netherlands
RECRUITINGCanisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, Netherlands
RECRUITINGGelre Hospitals
Apeldoorn, Netherlands
RECRUITINGDeventer Hospital
Deventer, Netherlands
RECRUITINGZiekenhuis Gelderse Vallei
Ede, Netherlands
RECRUITINGMedisch Spectrum Twente
Enschede, Netherlands
RECRUITINGMaxima Medical Center
Veldhoven, Netherlands
RECRUITINGMajor Adverse Cardiovascular Events (MACE)
Incidence of MACE, including myocardial infarction, cerebral infarction, heart failure, rupture, and peripheral vascular disease
Time frame: 2-year follow-up
SMART Risk score
Second Manifestations of ARTerial disease risk score is developed to determine the risk of recurrent vascular events based on clinical characteristics of the patients
Time frame: Baseline
CAR-test results
Percentage of vasodilation/vasoconstriction to the CAR test at the common carotid artery at baseline
Time frame: Baseline and 6-weeks after operation
CAR-test results
Magnitude of the blood flow and perfusion response
Time frame: Baseline and 6-weeks after operation
CAR-test results
Timing of the blood flow and perfusion response
Time frame: Baseline and 6-weeks after operation
CAR-test results
Blood pressure responses
Time frame: Baseline and 6-weeks after operation
CAR-test results
Heart rate responses
Time frame: Baseline and 6-weeks after operation
CAR-test results
Changes after treatment
Time frame: Baseline and 6-weeks after operation
SphygmoCor parameters
Peripheral pressure measurements (PWA)
Time frame: Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
Central pressure measurements (derived using a transfer function, PWA)
Time frame: Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
Abdominal pressure measurements (derived using a transfer function, PWA)
Time frame: Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
SEVR
Time frame: Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
ED
Time frame: Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
PWV
Time frame: Baseline, 6-weeks, 1 year and 2 year after operation
SphygmoCor parameters
Change in Peripheral pressure measurements (PWA) after treatment
Time frame: Baseline and 6-weeks after operation
SphygmoCor parameters
Change in Central pressure measurements (derived using a transfer function, PWA) after treatment
Time frame: Baseline and 6-weeks after operation
SphygmoCor parameters
Change in Abdominal pressure measurements (derived using a transfer function, PWA) after treatment
Time frame: Baseline and 6-weeks after operation
SphygmoCor parameters
Change in SEVR after treatment
Time frame: Baseline and 6-weeks after operation
SphygmoCor parameters
Change in ED after treatment
Time frame: Baseline and 6-weeks after operation
SphygmoCor parameters
Change in PWV after treatment
Time frame: Baseline and 6-weeks after operation
Score EQ-5D questionnaire
Patient reported outcomes measured by the general health questionnaire
Time frame: Baseline, 6-weeks, 1 year and 2 year after operation
Score IPQ-K questionnaire
Patient reported outcomes measured by the disease perception questionnaire
Time frame: Baseline, 6-weeks, 1 year and 2 year after operation
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