intermittent claudication peripheral arterial disease
Conditions
Interventions
None listed
Sponsors
Haaglanden Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 18 years of age and older
Exclusion criteria
Exclusion criteria: Unable to give informed consent or have a life expectancy of less than one year due to a non-cardiovascular risk profile.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.) Study parameters: ABI, TP, TBI, exercise/treadmill test, duplex ultrasonography and ACCmax calculations 2.) Primary endpoint: a. to evaluate the sensitivity of the ACCmax compared to the currently advised diagnostic method the ABI. Definitions of study parameters/endpoints All definitions pertinent to PAD are based on the 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Disease, in collaboration with the European Society for Vascular Surgery (ESVS).(10) ACCmax is a duplex-derived maximum systolic acceleration, and is calculated by computer at a single representative curve expressed in meters per second. The ACCmax is measured at the visually judged maximum derivative of the systolic phase as shown in Figure 1, and is measured distal to the stenosis.(15, 16) No additional software is necessary to obtain the ACCmax. As shown in figure 1, by clicking on two points in the screen there will be one tangent line. This tangent line must be placed manually at the maximal slope in the systolic phase at a single representative curve. The computer automatically calculates the acceleration of the tangent line at the steepest point in m/sec2 (= maximal systolic acceleration). ACCmax should not be confused with either acceleration time (AT) or mean systolic acceleration (ACCsys), which is the slope between beginning of systolic upstroke and peak of systole and is calculated using the following equation: ACCsys = ΔVsys/AT. Ankle-brachial Index of 50% arterial obstruction. Exercise/treadmill test is usually performed using the Strandness protocol at a speed of 3km/h and 10% slope. The test is stopped when the patient is unable to walk further because of pain, defining maximal walking distance. Furthermore, a post-exercise ankle SBP decrease of >30mmHg or a post-exercise ABI >20% is diagnostic of PAD.(10) Fontaine Classification: Clinical stages of lower extremity artery disease Toe pressure | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the sensitivity, specificity, positive and negative likelihood ratios of the ACCmax compared to duplex ultrasonography. Additionally, we will also evaluate the association between the diagnosis of PAD made in the primary objective and the following secondary endpoints: all clinical and haemodynamic outcomes are assessed within 1- and 5-year postindex measurement. a. Walking performance b. Mortality c. MACE d. Progression of disease as defined by the Fontaine Classification. Measured by: ABI; TP; DUS and ACCmax e. Revascularisation: number of procedures and time to revascularisation f. In-stent thrombosis Other study parameters 1. Investigate the interobserver variability (reproducibility) of ACCmax and ABI measurements 2. Investigate the correlation between the ABI and ACCmax 3. Investigate the correlation between the ABI and ACCmax in a resting state and after treadmill testing 4. Investigate the correlation between the TP and ACCmax 5. Investigate the correlation between the ACCmax and duplex ultrasound in patients with and without DM, and compare the results to ABI and TP. | — |
Countries
Netherlands
Outcome results
None listed