I70.2
Conditions
Interventions
Group 1: Empowerment Group
The study is expected to last 12 months for each participant.
At screening and at the end of the study after 12 months, in addition to a general physical examination, the pa
Sponsors
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent of the subject 2. Confirmed diagnosis of LEAD 3. LEAD stage Rutherford 1-5 4. No peripheral revascularization within the next 4 weeks
Exclusion criteria
Exclusion criteria: 1. Acute limb ischemia 2. LEAD Rutherford stage 6 3. Life expectancy less than 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of LDL-C < 55 mg/dL (yes or no) after 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| - combined endpoint of Major Adverse Cardiovascular Events (MACE; myocardial infarction, stroke cardiovascular death) and Major Adverse Limb Events (MALE; amputation, acute revascularization) - quality of life (QoL) / Adherence and Compliance - ankle brachial index (ABI) - walking distance (ICD=initial claudication distance and ACD=absolute claudication distance) - laboratory tests (e.g. inflammation and lipid parameters) - Amount of MACE in empowerment group compared to SOC group - Amount of MALE in empowerment group compared to SOC group | — |
Countries
Austria, Germany, Switzerland
Contacts
Public ContactChristine Espinola-Klein
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Outcome results
None listed