Predictive Value of Systolic Rise Time of the Plantar Arch on the Risk of Major Adverse Limb Events (MALE) and Major Adverse Cardiovascular Events (MACE) in Peripheral Artery Disease (PAD) at Critical Ischaemia Stage (TAMIS)

Centre Hospitalier Universitaire, Amiens

Status

Enrolling

Conditions

Major Adverse Limb Events

Peripheral Artery Disease

Critical Limb Ischemia

Major Adverse Cardiovascular Events

Hemodynamic Measure

Treatments

Procedure: hemodynamic measure of the Systolic Time Rise

Study type

Interventional

Funder types

Other

Identifiers

NCT06318767

PI2023_843_0141

Details and patient eligibility

About

Peripheral artery disease (PAD), vascular disease of atheromatous origin, is a frequent pathology, with a steady and significant increase in prevalence over the last decades. It has various symptoms ranging from mild arterial claudication to critical limb ischemia. The critical ischaemia stage in PAD is defined by rest pain or trophic disorders and is a special situation because of the number of cardiovascular deaths at 1 year (25%), 60% at 5 years and acute ischaemic recurrence at 1 year (25%).

It is a medico-surgical pathology. A haemodynamic marker is needed to monitor patients, as it is predictive of limb progression, cardiovascular events and mortality. The Systolic Rise Time (SRT) of the plantar footpad is a recently described haemodynamic measurement of proven value in the diagnosis of PAD. The aim of this study is to show the prognostic value of the Systolic Rise Time on Major Adverse Limb Events (MALE).

Enrollment

134 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patients at least 18 years old,
willing and able to provide written informed consent,
with documented atherosclerosis critical limb ischemia (pain rest and/or ulcer and gangrene manifestations)
with hemodynamic measures (ankle pressure less than 50mmHg and/or TBI less than 30mmHg and/or TcPO2 less than 30 mmHg),
followed or send to CHU Amiens Picardie, and eligible to chirurgical revascularization.

Exclusion criteria

with non atherosclerosis arteriopathy,
ineligible to the gold standard treatment such as the chirurgical revascularization,
with life expectancy less than 3 months.