Impact of Stress on Cardiovascular Events in Patients with Peripheral Arterial Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), Coronary Heart Disease (CHD) Death, or chronic limb ischemia and amputation [Time frame: Baseline, after 6 months, after 12 months]
- Pychological stress [Time frame: Baseline, after 6 months, after 12 months]
- Heart rate variability (HRV) [Time frame: Baseline, after 6 months, after 12 months]
- Proinflammatory mediators - IL-6 [Time frame: Baseline, after 6 months, after 12 months]
- Proinflammatory mediators - IL-1ß [Time frame: Baseline, after 6 months, after 12 months]
- Proinflammatory mediators - TNFalpha [Time frame: Baseline, after 6 months, after 12 months]
- Proinflammatory mediators - hsCRP [Time frame: Baseline, after 6 months, after 12 months]
- Hair cortisol concentration [Time frame: Baseline, after 6 months, after 12 months]
Secondary outcome measures (10)
- Health-related quality of life [Time frame: Baseline, after 6 months, after 12 months]
- Ankle-brachial index (ABI) [Time frame: Baseline, after 6 months, after 12 months]
- Changes in functional capacity [Time frame: Baseline, after 6 months, after 12 months]
- LDL-Cholesterol [Time frame: Baseline, after 6 months, after 12 months]
- Serum-cortisol [Time frame: Baseline, after 6 months, after 12 months]
- Depression symptoms (BDI-II) [Time frame: Baseline, after 6 months, after 12 months]
- Anxiety symptoms (STAI) [Time frame: Baseline, after 6 months, after 12 months]
- PROMIS-Anger Scale [Time frame: Baseline, after 6 months, after 12 months]
- GHQ [Time frame: Baseline, after 6 months, after 12 months]
- Perceived Stress Scale [Time frame: Baseline, after 6 months, after 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, Uni — Essen
Identifiers
NCT: NCT06887101 · 23-11092-BO