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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06318767
Acronym
TAMIS
Enrollment
134
Registered
2024-03-19
Start date
2024-03-07
Completion date
2026-09-01
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Limb Ischemia, Hemodynamic Measure, Major Adverse Cardiovascular Events, Major Adverse Limb Events, Peripheral Artery Disease

Keywords

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

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).

Interventions

OTHERhemodynamic 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

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
occurrence of limb ischemia6 months

Countries

France

Contacts

CONTACTSimon Soudet, Dr
soudet.simon@chu-amiens.fr03 22 88 72 89

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026