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


- candidate number15273
- NTR NumberNTR4117
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-aug-2013
- Secondary IDsDick Thijssen NL46109.091.13
- Public TitleImprovement of prognosis in patients with peripheral artery disease using a novel test.
- Scientific TitleThe prognostic role of the carotid artery reactivity test in patients with peripheral artery disease
- ACRONYMPrognosis CAR-PAD
- hypothesisThe 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
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria- Patients with peripheral artery disease (Fontaine 2b-3-4)
- Ankle-Brachial index of <0.90
- ≥ 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-okt-2013
- planned closingdate31-dec-2018
- Target number of participants200
- Interventionsperformance of the carotid artery reactivity test at the entry of the study (in addition to the standard tests)
- Primary outcome-Occurrence of vascular complications
-Clinical progression of disease state (walking distance, Fontaine classification, amputation)
- Secondary outcome-Physiological progression of disease state (ankle-brachial index)
- Timepoints0, 1 and 3 years
- Trial web siten.a.
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Dick H.J. Thijssen
- CONTACT for SCIENTIFIC QUERIESDr. Dick H.J. Thijssen
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Centre Nijmegen
- PublicationsN/A
- Brief summaryBackground 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
- Main changes (audit trail)
- RECORD15-aug-2013 - 26-aug-2013


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