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 progression of the abdominal aorta aneurysm and development of cardiovascular events in patients…
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, and peripheral vascular disease).
Secondary outcome
The following secondary endpoints will be evaluated during the 2-year follow-up:
- SMART risk score;
- 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
-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
-AAA progression (in mm/year);
-AAA repair;
-AAA Rupture;
-Any other (S)AE ;
-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,
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 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 in comparison to the SMART risk score for
progression of the abdominal aorta aneurysm and development of cardiovascular
events in patients with an abdominal aorta 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.
Study design
Prospective, observational, explorative study.
Study burden and risks
In this prospective, observational, explorative study all patients will be
under surveillance 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 20 minutes and is
non-invasive) will be performed additional to the clinical visits. With these
extra measurements, we gain more knowledge about novel strategies to predict
AAA progression and related cardiovascular events. When confirming our
hypotheses, we expect we can introduce novel, non-invasive, simple technology
to improve decision-making pertaining to when and whether to treat the aneurysm
in AAA-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 abdominal aortic aneurysm (AAA), who is still under surveillance;
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 spams (score Rose-questionnaire *2);
5. 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;
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 | NL68953.091.19 |