Tonometry(1) and Duplex Ultrasound(2) to Predict CV Events in to be Treated Patients With an AAA
NCT ID: NCT04183426
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
194 participants
OBSERVATIONAL
2020-06-12
2027-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Canisius-Wilhelmina Hospital
OTHER
Gelderse Vallei Hospital
OTHER
Medisch Spectrum Twente
OTHER
Deventer Ziekenhuis
OTHER
Gelre Hospitals
OTHER
Maxima Medical Center
OTHER
Rijnstate Hospital
OTHER
Responsible Party
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Principal Investigators
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Michel Reijnen, MD, prof
Role: PRINCIPAL_INVESTIGATOR
Rijnstate Hospital
Locations
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Radboudumc
Nijmegen, Gelderland, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, Netherlands
Gelre Hospitals
Apeldoorn, , Netherlands
Deventer Hospital
Deventer, , Netherlands
Ziekenhuis Gelderse Vallei
Ede, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Maxima Medical Center
Veldhoven, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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One-Two-Treat Trial
Identifier Type: -
Identifier Source: org_study_id
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