Improvement of prognosis in patients with peripheral artery disease using a novel test.

Background of the study:

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.



Objective of the study:

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 population:

200 patients with peripheral artery disease



Primary study parameters/outcome of the study:

The occurrence of vascular complications and the progression of peripheral artery disease

The carotid artery reactivity-test will have independent prognostic value compared to the current, standard prognostic tests (i.e. ankle-brachial-index, walking distance) for patients with peripheral artery disease

0, 1 and 3 years

performance of the carotid artery reactivity test at the entry of the study (in addition to the standard tests)