The aim of this prospective 2-year follow-up study is to investigate the predictive capacity of the CAR-test for development of cardiovascular events after elective AAA repair in comparison to the SMART risk score. Secondary objectives are to…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the incidence of MACE during two year follow-up
(Major adverse cardiovascular events (MACE); including myocardial infarction,
cerebral infarction, heart failure, rupture, and peripheral vascular disease).
Secondary outcome
The following secondary endpoints will be evaluated during the 2-year follow-up:
- SMART risk score
- CAR-test results;
o Percentage of vasodilatation/vasoconstriction to the CAR-test at the common
carotid artery at baseline.
o Magnitude and timing of the blood flow and perfusion response
o Blood pressure and heart rate responses
o Changes after treatment
- SphygmoCor parameters;
o Peripheral pressure measurements (PWA)
o Central and abdominal pressure parameters (derived using a transfer
function) (PWA)
o Cardiac output parameters (SEVR, ED) (PWA)
o PWV
o Changes after treatment
- Score EQ-5D questionnaire
- Score IPQ-K questionnaire
Background 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 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 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 cardiovascular events in
patients with peripheral arterial disease.
Study objective
The aim of this prospective 2-year follow-up study is to investigate the
predictive capacity of the CAR-test for development of cardiovascular events
after elective AAA repair in comparison to the SMART risk score. Secondary
objectives are to investigate the predictive capacity of the post-operative
CAR-test for development of CV-events and to evaluate QoL scores to provide
insight if these scores can support clinical decision making.
Study design
Prospective and observational study.
Study burden and risks
In this prospective, observational, explorative study all surgical and medical
procedures will performed per standard of care at each participating
institutes. The study protocol will collect routine data and will not require
additional patient visits, since the extra measurements (CAR-test and
non-invasive arterial stiffness measurements, which takes approximately 30
minutes and is non-invasive) will be performed additional to the clinical
visits before and after repair. With these extra measurements, we gain more
knowledge about related cardiovascular events to an AAA. When confirming our
hypotheses, we expect we can introduce novel, non-invasive, simple technology
to support clinical decision-making pertaining to when and whether to treat the
aneurysm, but also alter (drug) treatment to reduce risk of cardiovascular
events per patient. The used techniques have no risk for the participants.
Whilst the CAR-test may cause mild discomfort, which is quickly alleviated
after the 3 minute time frame and does not result in any lasting effect. The
arterial stiffness measurements cause no discomfort.
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
Inclusion criteria
1. Male or female at least 18 years old;
2. Informed consent form understood and signed and patient agrees to follow-up
visits;
3. 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
1. Life expectancy < 2 years;
2. Psychiatric or other condition that may interfere with the study;
3. Participating in another clinical study, interfering on outcomes;
4. Increased risk for coronary spasms (score Rose-questionnaire >=2);
5. 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;
6. Recent (<3 months) presence of angina pectoris, myocardial infarction,
cerebral infarction, and/or heart failure, or PAD treatment.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL69359.091.19 |