Impact of Stress on Cardiovascular Events in Patients with Peripheral Arterial Disease

NCT ID: NCT06887101

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-21
• Study Completion Date: 2026-12-31

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.

Conditions

Peripheral Arterial Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with peripheral arterial disease.

No control group is planned for this trial.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universität Duisburg-Essen

OTHER

Sponsor Role: collaborator

University Hospital, Essen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen

Essen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Julia Lortz, MD

Role: CONTACT

julia.lortz@uk-essen.de

+49201723-84995

Facility Contacts

Julia Lortz, MD

Role: primary

julia.lortz@uk-essen.de

+49201723-84995

Other Identifiers

23-11092-BO

Identifier Type: -

Identifier Source: org_study_id