Clinical trial NCT06887101: Impact of Stress on Cardiovascular Events in Patients with Peripheral Arterial Disease
Official title: Impact of Stress on Cardiovascular Events in Patients with Peripheral Arterial Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Arterial Disease
Keywords: vascular diseases
cardiovascular diseases
ischemia
arteriosclerosis
stress
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
Collaborators: name: Universität Duisburg-Essen
First posted: 2025-03-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), Coronary Heart Disease (CHD) Death, or chronic limb ischemia and amputation
timeFrame: Baseline, after 6 months, after 12 months
measure: Pychological stress
timeFrame: Baseline, after 6 months, after 12 months
measure: Heart rate variability (HRV)
timeFrame: Baseline, after 6 months, after 12 months
measure: Proinflammatory mediators - IL-6
timeFrame: Baseline, after 6 months, after 12 months
measure: Proinflammatory mediators - IL-1ß
timeFrame: Baseline, after 6 months, after 12 months
measure: Proinflammatory mediators - TNFalpha
timeFrame: Baseline, after 6 months, after 12 months
measure: Proinflammatory mediators - hsCRP
timeFrame: Baseline, after 6 months, after 12 months
measure: Hair cortisol concentration
timeFrame: Baseline, after 6 months, after 12 months
Secondary outcomes:
measure: Health-related quality of life
timeFrame: Baseline, after 6 months, after 12 months
measure: Ankle-brachial index (ABI)
timeFrame: Baseline, after 6 months, after 12 months
measure: Changes in functional capacity
timeFrame: Baseline, after 6 months, after 12 months
measure: LDL-Cholesterol
timeFrame: Baseline, after 6 months, after 12 months
measure: Serum-cortisol
timeFrame: Baseline, after 6 months, after 12 months
measure: Depression symptoms (BDI-II)
timeFrame: Baseline, after 6 months, after 12 months
measure: Anxiety symptoms (STAI)
timeFrame: Baseline, after 6 months, after 12 months
measure: PROMIS-Anger Scale
timeFrame: Baseline, after 6 months, after 12 months
measure: GHQ
timeFrame: Baseline, after 6 months, after 12 months
measure: Perceived Stress Scale
timeFrame: Baseline, after 6 months, after 12 months
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen
Study officials:
References: