Peripheral Arterial Disease
Conditions
Keywords
vascular diseases, cardiovascular diseases, ischemia, arteriosclerosis, stress
Brief summary
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.
Detailed description
Based on World Health Organization data, atherosclerotic cardiovascular disease (CVD) is the leading cause of morbidity and mortality worldwide. Peripheral arterial disease (PAD) is a poly-vascular disease in multiple arterial beds mostly associated with high atherosclerotic burden. It is estimated that around 50 million people in Europe alone suffer from PAD and the prevalence increases with age. The cause of CVD, such as PAD, coronary artery disease (CAD) or cerebrovascular disease, is atherosclerosis, a systemic chronic inflammatory vascular disease. Patients with CVD are at increased risk of life-threatening complications such as acute limb events, stroke and myocardial infarction combined with an impaired quality of life. Acute and chronic stress affect the cardiovascular system. Numerous studies have shown the relationship between chronic stress and cardiovascular diseases. On the one hand, permanent negative stressors lead to cardiovascular diseases via different pathways such as the hypothalamic-pituitary-adrenal (HPA) axis or the autonomic nervous system, and, on the other hand, stress can aggravate an already existing CVD. In addition, cardiovascular risk factors like hypertension and hypercholesteremia are negatively influenced by stress. Stress as a cardiovascular risk factor is receiving increasing attention, leading to its recognition in current guidelines on cardiovascular disease prevention. Due to the demographic development of an ageing population and the simultaneous increase in atherogenic risk factors, a further rise of patients with CVD will be expected in the future. Thus, sufficient assessment of cardiovascular risk in patients with PAD and adequate stress evaluation are elementary. However, there is a lack of consensus about the definition and measurement of stress. Therefore, the investigators aim to evaluate and compare the efficiency of different stress measuring methods depending on the occurrence of major adverse cardiovascular events (MACE) and major adverse limb events (MALE) in patients with PAD.
Interventions
None listed
Sponsors
Universität Duisburg-Essen
University Hospital, Essen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of lower extremity PAD based on: * 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 * intermittent claudication and one or more of either an ankle brachial index (ABI) of less than 0.90 or a peripheral artery stenosis (≥50%) documented by angiography or duplex ultrasound or carotid revascularization or asymptomatic carotid artery stenosis of at least 50% diagnosed by duplex ultrasound or angiography
Exclusion criteria
* atrial fibrillation * high premature ventricular contractions burden * pacemaker with constant ventricular pacing * antiarrhythmic drugs class I or III
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), Coronary Heart Disease (CHD) Death, or chronic limb ischemia and amputation | Baseline, after 6 months, after 12 months | 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 | Baseline, after 6 months, after 12 months | 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) | Baseline, after 6 months, after 12 months | 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 | Baseline, after 6 months, after 12 months | IL-6 is measured in pg/ml. Standard value is under 2.7 pg/ml. Higher values indicate an increased stress level |
| Proinflammatory mediators - IL-1ß | Baseline, after 6 months, after 12 months | IL-1ß is measured in pg/ml. Standard value is under 5 pg/ml. Higher values indicate an increased stress level |
| Proinflammatory mediators - TNFalpha | Baseline, after 6 months, after 12 months | TNFalpha is measured in pg/ml. Standard value is under 2.8 pg/ml. Higher values indicate an increased stress level |
| Proinflammatory mediators - hsCRP | Baseline, after 6 months, after 12 months | High sensitive-c-reactive protein (hsCRP) is measured in mg/dl. Standard value is under 0.02 mg/dl. Higher values indicate an increased stress level |
| Hair cortisol concentration | Baseline, after 6 months, after 12 months | Hair cortisol is reliable biomarker of chronic stress that offers a retrospective non-invasive measurement of long-term HPA-axis activity over several weeks or months. The cortisol concentration, measured in pg/ml, of a 3 cm hair segment using liquid chromatography tandem mass spectrometry will be analyzed. Higher values indicate an increased stress level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GHQ | Baseline, after 6 months, after 12 months | The GHQ assesses general distress and consists of 12 items. Respondents' scores range from 0 to 36, where higher scores correspond to increased distress |
| Health-related quality of life | Baseline, after 6 months, after 12 months | 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 |
| Perceived Stress Scale | Baseline, after 6 months, after 12 months | The Perceived Stress Scale-10 item version is a short tool for the assessment of how individuals perceive stress in their lives. The values range from 0 to 40. Higher values indicate higher perceived stress. (l) In-treatment assessments: at the start of each intervention module (weekly), the following assessment instruments will be applied: Distress Thermometer (DT), Patient Health Questionnaire-4 (PHQ-4) and self-generated measures to assess coping skills and self-efficacy |
| Ankle-brachial index (ABI) | Baseline, after 6 months, after 12 months | 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 | Baseline, after 6 months, after 12 months | Changes in functional capacity will be recorded using the established 6-minute walk test |
| LDL-Cholesterol | Baseline, after 6 months, after 12 months | Low density lipoprotein (LDL) is measured in mg/dl |
| Serum-cortisol | Baseline, after 6 months, after 12 months | Serum-Cortisol is measured in mol/l |
| Depression symptoms (BDI-II) | Baseline, after 6 months, after 12 months | The BDI-II is a self-report questionnaire comprising 21 items that assess depression severity. Its reliability and validity have been established through various studies among diverse populations and cultural backgrounds. Higher scores indicates increased depression symptoms |
| Anxiety symptoms (STAI) | Baseline, after 6 months, after 12 months | The STAI is the most authoritative tool for assessing anxiety in adults, precisely distinguishing between transient state anxiety and persistent trait anxiety. The STAI measures anxiety with 20 items and has a range of 20 to 80. A higher score indicates more pronounced anxiety. |
| PROMIS-Anger Scale | Baseline, after 6 months, after 12 months | The PROMIS Anger scale comprises eight items that evaluate various aspects of anger. Scores on the scale range from 8 to 40, with higher scores indicating greater levels of anger |
Countries
Germany
Contacts
Primary ContactJulia Lortz, MD
Outcome results
None listed