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| Name | Class |
|---|---|
| Radboud University Medical Center | OTHER |
| Canisius-Wilhelmina Hospital | OTHER |
| Gelderse Vallei Hospital | OTHER |
| Medisch Spectrum Twente |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carotid Artery Reactivity test (CAR test) | Diagnostic 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. | ||
| Arterial Stiffness | Diagnostic Test | 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:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiovascular Events (MACE) | Incidence of MACE, including myocardial infarction, cerebral infarction, heart failure, rupture, and peripheral vascular disease | 2-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
| CAR-test results |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic characteristics | Age | Baseline |
| Demographic characteristics | Gender | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michel Reijnen, MD, prof | Contact | 0880057282 | MReijnen@rijnstate.nl | |
| Jenske Vermeulen, MSc. | Contact | 0880057282 | JVermeulen@rijnstate.nl |
| Name | Affiliation | Role |
|---|---|---|
| Michel Reijnen, MD, prof | Rijnstate Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Recruiting | Nijmegen | Gelderland | 6525GA | Netherlands |
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| OTHER |
| Deventer Ziekenhuis | OTHER |
| Gelre Hospitals | OTHER |
| Maxima Medical Center | OTHER |
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Percentage of vasodilation/vasoconstriction to the CAR test at the common carotid artery at baseline
| Baseline and 6-weeks after operation |
| CAR-test results | Magnitude of the blood flow and perfusion response | Baseline and 6-weeks after operation |
| CAR-test results | Timing of the blood flow and perfusion response | Baseline and 6-weeks after operation |
| CAR-test results | Blood pressure responses | Baseline and 6-weeks after operation |
| CAR-test results | Heart rate responses | Baseline and 6-weeks after operation |
| CAR-test results | Changes after treatment | Baseline and 6-weeks after operation |
| SphygmoCor parameters | Peripheral pressure measurements (PWA) | Baseline, 6-weeks, 1 year and 2 year after operation |
| SphygmoCor parameters | Central pressure measurements (derived using a transfer function, PWA) | Baseline, 6-weeks, 1 year and 2 year after operation |
| SphygmoCor parameters | Abdominal pressure measurements (derived using a transfer function, PWA) | Baseline, 6-weeks, 1 year and 2 year after operation |
| SphygmoCor parameters | SEVR | Baseline, 6-weeks, 1 year and 2 year after operation |
| SphygmoCor parameters | ED | Baseline, 6-weeks, 1 year and 2 year after operation |
| SphygmoCor parameters | PWV | Baseline, 6-weeks, 1 year and 2 year after operation |
| SphygmoCor parameters | Change in Peripheral pressure measurements (PWA) after treatment | Baseline and 6-weeks after operation |
| SphygmoCor parameters | Change in Central pressure measurements (derived using a transfer function, PWA) after treatment | Baseline and 6-weeks after operation |
| SphygmoCor parameters | Change in Abdominal pressure measurements (derived using a transfer function, PWA) after treatment | Baseline and 6-weeks after operation |
| SphygmoCor parameters | Change in SEVR after treatment | Baseline and 6-weeks after operation |
| SphygmoCor parameters | Change in ED after treatment | Baseline and 6-weeks after operation |
| SphygmoCor parameters | Change in PWV after treatment | Baseline and 6-weeks after operation |
| Score EQ-5D questionnaire | Patient reported outcomes measured by the general health questionnaire | Baseline, 6-weeks, 1 year and 2 year after operation |
| Score IPQ-K questionnaire | Patient reported outcomes measured by the disease perception questionnaire | Baseline, 6-weeks, 1 year and 2 year after operation |
| Demographic characteristics | If current smoker | Baseline |
| Demographic characteristics | Height | Baseline |
| Demographic characteristics | Weight | Baseline |
| Demographic characteristics | ASA class | Baseline |
| Demographic characteristics | Medical history | Baseline |
| Demographic characteristics | Blood pressure | Baseline |
| Demographic characteristics | Heart rate | Baseline |
| Demographic characteristics | Cardiac measurements | Baseline |
| Demographic characteristics | SVS class | Baseline |
| Preoperative anatomic characteristics before primary repair procedure | AAA sac diameter | Baseline |
| Preoperative anatomic characteristics before primary repair procedure | Infrarenal aortic neck lumen diameter | Baseline |
| Preoperative anatomic characteristics before primary repair procedure | Proximal non-aneurysmal aortic neck length | Baseline |
| Preoperative anatomic characteristics before primary repair procedure | Proximal aortic neck angle | Baseline |
| Preoperative anatomic characteristics before primary repair procedure | Aneurysm blood lumen diameter | Baseline |
| Preoperative anatomic characteristics before primary repair procedure | Common iliac artery diameters | Baseline |
| Preoperative anatomic characteristics before primary repair procedure | Blood lumen diameter | Baseline |
| Procedure and discharge details of intervention | Type of procedure | At time of procedure |
| Procedure and discharge details of intervention | Anesthesia type | At time of procedure |
| Procedure and discharge details of intervention | Access type | At time of procedure |
| Procedure and discharge details of intervention | Used stent lengths | At time of procedure |
| Procedure and discharge details of intervention | Contrast volume used | At time of procedure |
| Procedure and discharge details of intervention | Total procedure time | At time of procedure |
| Procedure and discharge details of intervention | Immediate procedural technical success | At time of procedure |
| Procedure and discharge details of intervention | Complications pre procedure | During procedure |
| Procedure and discharge details of intervention | Complications post procedure | Up to 2 years |
| Procedure and discharge details of intervention | Additional procedures estimated blood loss | During procedure |
| Procedure and discharge details of intervention | Blood transfusion | During procedure |
| Procedure and discharge details of intervention | Concomitant procedures | Up to 2 years |
| Procedure and discharge details of intervention | Time in ICU | After procedure till discharge |
| Procedure and discharge details of intervention | Time to hospital discharge | After procedure till discharge |
| Medications | Dose of Anti-platelets | During 2-year follow up |
| Medications | Dose of Anti-coagulants | During 2-year follow up |
| Medications | Dose of Anti-hypertensives | During 2-year follow up |
| Medications | Dose of Statins | During 2-year follow up |
| Medications | Dose of Beta-blockers | During 2-year follow up |
| Medications | Dose of Sympathicomimetics | During 2-year follow up |
| Laboratory test results | Hemoglobin | 2-year follow-up |
| Laboratory test results | Serum creatinine | 2-year follow-up |
| Laboratory test results | Cholesterol | 2-year follow-up |
| Laboratory test results | eGFR | 2-year follow-up |
| Laboratory test results | CRP | 2-year follow-up |
| Parameters during follow-up | Any type of endoleak | 2-year follow-up |
| Parameters during follow-up | AAA sac expansion | 2-year follow-up |
| Parameters during follow-up | Any other (S)AE | 2-year follow-up |
| Canisius Wilhelmina Ziekenhuis | Recruiting | Nijmegen | Gelderland | 6532SZ | Netherlands |
|
| Gelre Hospitals | Recruiting | Apeldoorn | Netherlands |
|
| Deventer Hospital | Recruiting | Deventer | Netherlands |
|
| Ziekenhuis Gelderse Vallei | Recruiting | Ede | Netherlands |
|
| Medisch Spectrum Twente | Recruiting | Enschede | Netherlands |
|
| Maxima Medical Center | Recruiting | Veldhoven | Netherlands |
|
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| ID | Term |
|---|---|
| D059289 | Vascular Stiffness |
| ID | Term |
|---|---|
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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