Abdominal Aortic Aneurysm, Cardiovascular Events
Conditions
Keywords
Functional Response, Abdominal Aortic Aneurysm, Cardiovascular Events
Brief 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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTCarotid 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_TESTArterial 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
Radboud University Medical Center
Canisius-Wilhelmina Hospital
Gelderse Vallei Hospital
Medisch Spectrum Twente
Deventer Ziekenhuis
Gelre Hospitals
Maxima Medical Center
Rijnstate Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiovascular Events (MACE) | 2-year follow-up | Incidence of MACE, including myocardial infarction, cerebral infarction, heart failure, rupture, and peripheral vascular disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SMART Risk score | Baseline | Second Manifestations of ARTerial disease risk score is developed to determine the risk of recurrent vascular events based on clinical characteristics of the patients |
| CAR-test results | Baseline and 6-weeks after operation | Percentage of vasodilation/vasoconstriction to the CAR test at the common carotid artery at baseline |
| SphygmoCor parameters | Baseline, 6-weeks, 1 year and 2 year after operation | Peripheral pressure measurements (PWA) |
| Score EQ-5D questionnaire | Baseline, 6-weeks, 1 year and 2 year after operation | Patient reported outcomes measured by the general health questionnaire |
| Score IPQ-K questionnaire | Baseline, 6-weeks, 1 year and 2 year after operation | Patient reported outcomes measured by the disease perception questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Demographic characteristics | Baseline | Age |
| Preoperative anatomic characteristics before primary repair procedure | Baseline | AAA sac diameter |
| Medications | During 2-year follow up | Dose of Anti-platelets |
| Procedure and discharge details of intervention | At time of procedure | Type of procedure |
| Laboratory test results | 2-year follow-up | Hemoglobin |
| Parameters during follow-up | 2-year follow-up | Any type of endoleak |
Countries
Netherlands
Contacts
Primary ContactMichel Reijnen, MD, prof
Backup ContactJenske Vermeulen, MSc.
Outcome results
None listed