Atherosclerotic cardiovascular disease is the leading cause of morbidity and mortality worldwide. Patients with peripheral arterial disease are at increased risk suffering from major adverse cardiac and limb events. Acute and chronic stress affect the cardiovascular system. Long-term negative stressors lead to cardiovascular diseases and can aggravate already existing cardiovascular diseases. However, current guidelines on cardiovascular disease prevention highlight stress as a cardiovascular risk factor there is a lack of consensus about the definition and measurement of stress. The aim of the proposed trial is to evaluate different stress measuring methods in patients with PAD depending on the occurrence of cardiovascular events.
Limb bypass surgery or
aorta-femoral bypass surgery or
percutaneous transluminal angioplasty revascularization of the iliac or infrainguinal arteries or
limb or foot amputation for arterial vascular disease or
atrial fibrillation
high premature ventricular contractions burden
pacemaker with constant ventricular pacing
antiarrhythmic drugs class I or III
The recruitment process and examinations will take place at the Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen.
Cohort
Prospective
Not listed
Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), Coronary Heart Disease (CHD) Death, or chronic limb ischemia and amputation
Based on the COMPASS trial MACE and MALE includes the composite of cardiovascular death, myocardial infarction, acute limb ischaemia, chronic limb ischaemia and amputation. MACE and MALE will be evaluated at baseline and after 6 and 12 months
Pychological stress
Pychological stress is evaluated by a composite psychometric measure of stress level by using a mean rank at baseline and after 1 year. It is based on a published RCT by Blumenthal et al. and includes the Beck Depression Inventory II (BDI-II), State-Trait Anxiety inventory (STAI), Patient-Reported Outcomes Measurement Information System (PROMIS) Anger, General Health Questionnaire (GHQ) and Perceived Stress Scale (PSS). A range from 1 to 147 was present with higher scores suggestive of better function
Heart rate variability (HRV)
Heart rate variability (HRV) is an indirect marker of autonomic nervous system activity and describes the oscillations between the R-R intervals in the electrocardiogram. It allows a relatively superficial insight into the heart-brain interaction and reflects the psycho-emotional status such as stress or anxiety. According to the guidelines we chose a short-time HRV with 5 minutes of recording
Proinflammatory mediators - IL-6
IL-6 is measured in pg/ml. Standard value is under 2.7 pg/ml. Higher values indicate an increased stress level
Health-related quality of life
We will apply two instrument to measure health-related quality of life. Namely the Short Form-36 health questionnaire and the European Quality of Life 5 Dimensions 5 Level survey (EQ-5D-5L). The SF-36 is an eight-dimensional scale consisting of 36 items. It assesses health-related quality of life based on physical, social, and psychological functioning, role behavior due to physical and psychological functional impairment, physical pain, general health perception, and vitality. The EQ-5D-5L consists of five health-related dimensions that can be assessed at five levels. In addition, the questionnaire contains a visual analog scale for assessing general health
Ankle-brachial index (ABI)
The lower systolic ankle pressure is set in relation to the systolic blood pressure of the upper extremity. The lowest calculated ABI will be used. Normal values are 0.9 to 1.2. ABI values below 0.9 are indicative of PAD, with an ABI below 0.5 showing severe limb ischaemia
Changes in functional capacity
Changes in functional capacity will be recorded using the established 6-minute walk test
LDL-Cholesterol
Low density lipoprotein (LDL) is measured in mg/dl
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University Hospital, Essen
Lead sponsor
Universität Duisburg-Essen
Collaborator
