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
NCT06318767 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134
Last updated 2024-03-19
Summary
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).
Conditions
- Major Adverse Limb Events
- Major Adverse Cardiovascular Events
- Peripheral Artery Disease
- Critical Limb Ischemia
- Hemodynamic Measure
Interventions
- PROCEDURE
-
hemodynamic measure of the Systolic Time Rise
The hemodynamic measure of the Systolic Time Rise will be added in the routine doppler echography, planned in preoperative, postoperative and at 6 months of following up. This measure is taken on the foot, with ultrasound probe.
Sponsors & Collaborators
-
Centre Hospitalier Universitaire, Amiens
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-04
- Primary Completion
- 2025-03-31
- Completion
- 2025-09-30
Countries
- France
Study Locations
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