Brief Title
Tonometry and Duplex Ultrasound to Predict AAA Progression and CV Events in Aneurysm Patients (1-2-3 Trial)
Official Title
Tonometry (1) and Duplex Ultrasound (2) to Predict Abdominal Aorta Aneurysm (3) Progression and Cardiovascular Events in Aneurysm Patients
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, highlighting the need to explore the
potential of novel techniques. Both progression of AAA and CV events are strongly linked to
vascular health. In 2013, the SMART risk score is 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 recently 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 in comparison to the SMART risk score for the development of cardiovascular
events in patients with an abdominal aortic aneurysm who have not yet reached the treatment
threshold. This could aid clinical decision making in the need for (surgical) intervention,
but also alter (drug) treatment to reduce risk of cardiovascular events. Secondary objectives
are to investigate the predictive capacity of the CAR-test for progression of the abdominal
aortic aneurysm, and to evaluate QoL scores in patients under surveillance for AAA. The aim
is to provide insight if these scores can help clinical decision making.
Detailed Description
The investigators will include 167 patients under surveillance for AAA who are all currently
under the threshold for repair (i.e. AAA diameter 40-50 mm for men and 35-45 mm for women).
Participants will be recruited from all collaborating hospitals (Radboudumc, Rijnstate, CWZ)
after providing written informed consent. Additionally, 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.
In this observational, prospective study, a total of 167 patients under surveillance for an
AAA, who are currently under threshold for repair (i.e. AAA diameter 40-50 mm for men and
35-44 mm for women), 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), the investigators will perform the CAR-test (10-min)
and non-invasive arterial stiffness measures (PWA and PWV with the SphygmoCor device (10-min)
one time as baseline. Furthermore, the investigators will ask patients to complete a
questionnaire about the quality of their life (Appendix 1). A second questionnaire tries to
clarify the disease experience of the patients and can be found in Appendix 2. Both
questionnaires will be asked to be completed at the start and the end of the study.
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 AAA
progression (in mm/year) and the ability of the CAR parameter and arterial stiffness
parameters to predict CV-events.
Study Type
Observational
Primary Outcome
Major Adverse Cardiovascular Events (MACE)
Secondary Outcome
SMART risk score
Condition
Abdominal Aortic Aneurysm
Intervention
Carotid Artery Reactivity test (CAR test)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
167
Start Date
July 1, 2019
Completion Date
September 2023
Primary Completion Date
May 1, 2023
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 abdominal aortic aneurysm (AAA), who is still under surveillance;
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; this questionnaire
can be found in Appendix 3);
- Presence of Raynaud's phenomenon, 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.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Michel Rijnen, MD, prof, ,
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT03989011
Organization ID
NL68953.091.19
Responsible Party
Sponsor
Study Sponsor
Rijnstate Hospital
Collaborators
Radboud University Medical Center
Study Sponsor
Michel Rijnen, MD, prof, Principal Investigator, Rijnstate Hospital
Verification Date
November 2022