Clinical trial NCT04183426: Tonometry(1) and Duplex Ultrasound(2) to Predict CV Events in to be Treated Patients With an AAA
Official title: Tonometry(1) and Duplex Ultrasound(2) to Predict Cardiovascular Events in to be Treated Patients With an Abdominal Aortic Aneurysm (One-Two-Treat Trial)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abdominal Aortic Aneurysm
Cardiovascular Events
Keywords: Functional Response
Abdominal Aortic Aneurysm
Cardiovascular Events
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
name: Canisius-Wilhelmina Hospital
name: Gelderse Vallei Hospital
name: Medisch Spectrum Twente
name: Deventer Ziekenhuis
name: Gelre Hospitals
name: Maxima Medical Center
First posted: 2019-12-03
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Major Adverse Cardiovascular Events (MACE)
timeFrame: 2-year follow-up
Secondary outcomes:
measure: SMART Risk score
timeFrame: Baseline
measure: CAR-test results
timeFrame: Baseline and 6-weeks after operation
measure: CAR-test results
timeFrame: Baseline and 6-weeks after operation
measure: CAR-test results
timeFrame: Baseline and 6-weeks after operation
measure: CAR-test results
timeFrame: Baseline and 6-weeks after operation
measure: CAR-test results
timeFrame: Baseline and 6-weeks after operation
measure: CAR-test results
timeFrame: Baseline and 6-weeks after operation
measure: SphygmoCor parameters
timeFrame: Baseline, 6-weeks, 1 year and 2 year after operation
measure: SphygmoCor parameters
timeFrame: Baseline, 6-weeks, 1 year and 2 year after operation
measure: SphygmoCor parameters
timeFrame: Baseline, 6-weeks, 1 year and 2 year after operation
measure: SphygmoCor parameters
timeFrame: Baseline, 6-weeks, 1 year and 2 year after operation
measure: SphygmoCor parameters
timeFrame: Baseline, 6-weeks, 1 year and 2 year after operation
measure: SphygmoCor parameters
timeFrame: Baseline, 6-weeks, 1 year and 2 year after operation
measure: SphygmoCor parameters
timeFrame: Baseline and 6-weeks after operation
measure: SphygmoCor parameters
timeFrame: Baseline and 6-weeks after operation
measure: SphygmoCor parameters
timeFrame: Baseline and 6-weeks after operation
measure: SphygmoCor parameters
timeFrame: Baseline and 6-weeks after operation
measure: SphygmoCor parameters
timeFrame: Baseline and 6-weeks after operation
measure: SphygmoCor parameters
timeFrame: Baseline and 6-weeks after operation
measure: Score EQ-5D questionnaire
timeFrame: Baseline, 6-weeks, 1 year and 2 year after operation
measure: Score IPQ-K questionnaire
timeFrame: Baseline, 6-weeks, 1 year and 2 year after operation
Other outcomes:
measure: Demographic characteristics
timeFrame: Baseline
measure: Demographic characteristics
timeFrame: Baseline
measure: Demographic characteristics
timeFrame: Baseline
measure: Demographic characteristics
timeFrame: Baseline
measure: Demographic characteristics
timeFrame: Baseline
measure: Demographic characteristics
timeFrame: Baseline
measure: Demographic characteristics
timeFrame: Baseline
measure: Demographic characteristics
timeFrame: Baseline
measure: Demographic characteristics
timeFrame: Baseline
measure: Demographic characteristics
timeFrame: Baseline
measure: Demographic characteristics
timeFrame: Baseline
measure: Preoperative anatomic characteristics before primary repair procedure
timeFrame: Baseline
measure: Preoperative anatomic characteristics before primary repair procedure
timeFrame: Baseline
measure: Preoperative anatomic characteristics before primary repair procedure
timeFrame: Baseline
measure: Preoperative anatomic characteristics before primary repair procedure
timeFrame: Baseline
measure: Preoperative anatomic characteristics before primary repair procedure
timeFrame: Baseline
measure: Preoperative anatomic characteristics before primary repair procedure
timeFrame: Baseline
measure: Preoperative anatomic characteristics before primary repair procedure
timeFrame: Baseline
measure: Procedure and discharge details of intervention
timeFrame: At time of procedure
measure: Procedure and discharge details of intervention
timeFrame: At time of procedure
measure: Procedure and discharge details of intervention
timeFrame: At time of procedure
measure: Procedure and discharge details of intervention
timeFrame: At time of procedure
measure: Procedure and discharge details of intervention
timeFrame: At time of procedure
measure: Procedure and discharge details of intervention
timeFrame: At time of procedure
measure: Procedure and discharge details of intervention
timeFrame: At time of procedure
measure: Procedure and discharge details of intervention
timeFrame: During procedure
measure: Procedure and discharge details of intervention
timeFrame: Up to 2 years
measure: Procedure and discharge details of intervention
timeFrame: During procedure
measure: Procedure and discharge details of intervention
timeFrame: During procedure
measure: Procedure and discharge details of intervention
timeFrame: Up to 2 years
measure: Procedure and discharge details of intervention
timeFrame: After procedure till discharge
measure: Procedure and discharge details of intervention
timeFrame: After procedure till discharge
measure: Medications
timeFrame: During 2-year follow up
measure: Medications
timeFrame: During 2-year follow up
measure: Medications
timeFrame: During 2-year follow up
measure: Medications
timeFrame: During 2-year follow up
measure: Medications
timeFrame: During 2-year follow up
measure: Medications
timeFrame: During 2-year follow up
measure: Laboratory test results
timeFrame: 2-year follow-up
measure: Laboratory test results
timeFrame: 2-year follow-up
measure: Laboratory test results
timeFrame: 2-year follow-up
measure: Laboratory test results
timeFrame: 2-year follow-up
measure: Laboratory test results
timeFrame: 2-year follow-up
measure: Parameters during follow-up
timeFrame: 2-year follow-up
measure: Parameters during follow-up
timeFrame: 2-year follow-up
measure: Parameters during follow-up
timeFrame: 2-year follow-up
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
state: Gelderland
city: Apeldoorn
country: Netherlands
facility: Gelre Hospitals
city: Deventer
country: Netherlands
facility: Deventer Hospital
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Veldhoven
country: Netherlands
facility: Maxima Medical Center
Study officials:
affiliation: Rijnstate Hospital
name: Michel Reijnen, MD, prof
role: PRINCIPAL_INVESTIGATOR
References: