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

NCT ID: NCT06318767

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-04
• Study Completion Date: 2025-09-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens

Amiens, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Simon Soudet, Dr

Role: CONTACT

soudet.simon@chu-amiens.fr

03 22 88 72 89

Facility Contacts

SOUDET Simon, MD

Role: primary

soudet.simon@chu-amiens.fr

03 22 88 72 89

Other Identifiers

PI2023_843_0141

Identifier Type: -

Identifier Source: org_study_id