Tonometry(1) and Duplex Ultrasound(2) to Predict CV Events in to be Treated Patients With an AAA
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRijnstate Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial population
Patients with an AAA who will be scheduled for repair, will be included. AAA patients will be recruited from all collaborating hospitals (Radboudumc, Rijnstate, CWZ), who provide written informed consent. Additionally, also AAA-patients under surveillance of general practitioners are eligible (and will be contacted through the hospital-links), since the nature of the tests allow for performing all tests at the general practitioners' office.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Carotid Artery Reactivity test (CAR test)
Diagnostic testThe 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.
Arterial Stiffness
Diagnostic testThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Major Adverse Cardiovascular Events (MACE)
Incidence of MACE, including myocardial infarction, cerebral infarction, heart failure, rupture, and peripheral vascular disease
Time frame
2-year follow-upSecondary outcomes
1
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
Baseline2
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 operation3
CAR-test results
Magnitude of the blood flow and perfusion response
Time frame
Baseline and 6-weeks after operation4
CAR-test results
Timing of the blood flow and perfusion response
Time frame
Baseline and 6-weeks after operationOther outcomes
1
Demographic characteristics
Age
Time frame
Baseline2
Demographic characteristics
Gender
Time frame
Baseline3
Demographic characteristics
If current smoker
Time frame
Baseline4
Demographic characteristics
Height
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rijnstate Hospital
Lead sponsor
Radboud University Medical Center
Collaborator
Canisius-Wilhelmina Hospital
Collaborator
Gelderse Vallei Hospital
Collaborator
Medisch Spectrum Twente
Collaborator
Deventer Ziekenhuis
Collaborator
Gelre Hospitals
Collaborator
Maxima Medical Center
Collaborator
Source ClinicalTrials.gov