Assessing the Systolic Rise Time's ability to predict limb and cardiovascular events in severe peripheral artery disease
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
This study is testing if a specific measurement from the foot can help predict serious problems with limbs and heart health in people with severe peripheral artery disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT06318767 on ClinicalTrials.gov |
What this trial studies
This study investigates the prognostic value of the Systolic Rise Time (SRT) of the plantar arch in patients with critical limb ischemia due to peripheral artery disease (PAD). It aims to determine how well this hemodynamic measure can predict major adverse limb events (MALE) and major adverse cardiovascular events (MACE). By monitoring SRT, the study seeks to provide a reliable marker for assessing the risk of progression in PAD and associated cardiovascular complications. The research will involve patients who meet specific criteria related to their condition and hemodynamic measurements.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with documented atherosclerosis critical limb ischemia and specific hemodynamic measures.
Not a fit: Patients with non-atherosclerotic arteriopathy or those ineligible for surgical revascularization may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and management of patients with critical limb ischemia, potentially reducing adverse events.
How similar studies have performed: While the Systolic Rise Time is a relatively new measure, similar hemodynamic assessments have shown promise in predicting outcomes in vascular diseases.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Amiens
- CHU Amiens — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Simon Soudet, Dr
- Email: soudet.simon@chu-amiens.fr
- Phone: 03 22 88 72 89
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.