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 | Recruiting

• 1 other identifier: PI2023_843_0141
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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

Keywords

major adverse limb events; major adverse cardiovascular events; peripheral artery disease; critical limb ischemia; hemodynamic measure

Outcome Measures

Primary Outcomes (1)

• occurrence of limb ischemia

  6 months

Interventions

hemodynamic measure of the Systolic Time Rise PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Central Study Contacts

Simon Soudet, Dr

CONTACT

03 22 88 72 89; soudet.simon@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: March 4, 2024
• Primary Completion: March 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)