To examine the 1- and 3-year prognostic value of the CAR-test in patients with peripheral artery disease regarding the occurrence of vascular complications and the progression of PAD
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
vasculaire aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The occurrence of vascular complications and the progression of peripheral
artery disease
Secondary outcome
n.a.
Background summary
Peripheral artery disease (PAD) is a common disease and is associated with
serious health problems. A number of clinical tests have been developed to
assess prognosis and progression of PAD, such as the ankle-brachial-index
(ABI). Previous studies have demonstrated that measures of cardiovascular
function significantly contribute to the predictive capacity of the ABI.
However, these previous studies used techniques that are expensive, invasive
and/or technically challenging.
The carotid artery reactivity(CAR)-test relates to the assessment of the
carotid artery diameter changes in response to a stimulus of the sympathetic
nervous system, induced by a cold pressor test (placing the hand in icy water).
In analogy with coronary vessels (but not with peripheral conduit arteries),
the carotid artery responds with a dilation (of ~10%). However, the presence of
cardiovascular risk/disease leads to an attenuation of the dilator response, or
could even lead to a small constriction of the carotid artery (of ~5%). This
simple, non-invasive and easy applicable test may contribute to the risk
stratification or prediction of complications of PAD patients. To date, no
previous study examined the potential prognostic value of the CAR-test in PAD
patients.
Study objective
To examine the 1- and 3-year prognostic value of the CAR-test in patients with
peripheral artery disease regarding the occurrence of vascular complications
and the progression of PAD
Study design
Observational, prospective cohort study
Study burden and risks
Performance of the CAR-test takes approximately 5 minutes and will be performed
immediately after the (planned) tests in the vascular laboratory (which takes
30 minutes). The CAR-test is non-invasive and associated with a minimal burden.
Therefore, the CAR-test is associated with a minimal burden for the patients,
whilst the results of this study may have important and novel clinical value,
potentially leading to a significant improvement in the clinical care of this
group of patients.
Philips van Leijdenlaan 15
Nijmegen 6525 EX
NL
Philips van Leijdenlaan 15
Nijmegen 6525 EX
NL
Listed location countries
Age
Inclusion criteria
- Patients with peripheral artery disease (Fontaine 2b-3-4)
- >= 18 years
- Mentally capable to sign an informed consent
Exclusion criteria
- Presence of Raynaud, chronic pain syndrome in upper limbs, shunt, open wound in upper limb and/or sclerodermia
- Recent (<6 months) intervention for coronary, central or peripheral artery disease
- Recent (<3 months) presence of unstable angina pectoris, myocardial infarction, cerebral infarction, and/or heartfailure.
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 | NL46109.091.13 |