RecruitingOBSERVATIONAL

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

This study aims to understand how stress impacts people living with Peripheral Arterial Disease (PAD). PAD is a common condition where narrowed blood vessels reduce blood flow, often to the legs. People with PAD are at higher risk of serious heart-related issues and problems with their limbs. We know that stress, both short-term and long-term, can affect the heart and blood vessels, and can worsen existing heart conditions. However, it's not always clear how best to define and measure stress in a way that helps doctors. This research will test different ways of measuring stress in PAD patients to see which methods best predict who might develop further heart and limb problems.

At a glance

Status

Recruiting

Sponsor

University Hospital, Essen

Enrolment target

300

Start

21 Apr 2023

Estimated completion

31 Dec 2026

Peripheral Arterial Disease

What is this study about?

Peripheral Arterial Disease (PAD) is a condition where narrowed blood vessels reduce blood flow, usually to your legs. This happens because of a build-up of fatty deposits called atherosclerosis – a bit like rust in pipes. Many people have PAD, and it's a worldwide health concern because it increases the risk of serious problems like heart attacks, strokes, and issues with the legs and feet that can sometimes be very severe.

We know that stress can have a big impact on our bodies, including our heart and circulatory system. Both sudden, intense stress and long-term, ongoing stress have been linked to heart diseases and can make existing conditions like PAD worse. Stress can also negatively affect other risk factors for heart disease, such as high blood pressure. While doctors recognise stress as an important factor, there isn't one clear way to define or measure it effectively in clinical practice. This means it's hard to consistently know how much stress a patient is experiencing and how it might be affecting their health.

This study wants to find better ways to measure stress in people with PAD. Researchers will be comparing different methods of measuring stress to see which ones are best at predicting who might develop serious heart problems or other complications. By doing this, they hope to improve how doctors assess and manage risk for people living with PAD, ultimately leading to better care and outcomes.

Key takeaways

This study explores how stress affects people with PAD.
It aims to find better ways to measure stress accurately.
Understanding stress may help predict future heart or limb problems in PAD patients.
Participants will have their stress levels assessed using various methods.
The study doesn't offer new treatments, but aims to improve future care.

Who may be eligible?

You might be able to join this study if you are 18 years or older and have a confirmed diagnosis of Peripheral Arterial Disease (PAD). This could be because you've had surgery on your leg or aorta, or procedures to open up narrowed arteries in your legs. It also includes those who have had a limb or foot amputation due to arterial disease, or if you experience leg pain when walking (known as intermittent claudication) and have specific test results showing narrowed arteries.

You would not be able to join the study if you have certain heart rhythm problems, such as atrial fibrillation or frequent extra heartbeats, or if you have a pacemaker that constantly paces your heart. Also, if you are taking certain types of medication for heart rhythm problems (specifically antiarrhythmic drugs class I or III), you would not be eligible. This is to make sure the study results are as clear and accurate as possible for the specific group of patients they are studying.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with Peripheral Arterial Disease (PAD)?
Have you *not* had certain heart rhythm issues like atrial fibrillation or frequent extra heartbeats?
Are you *not* taking specific heart rhythm medications (class I or III antiarrhythmics)?
Do you *not* have a pacemaker that constantly paces your heart?

Answer every question to see your result.

What does participation involve?

The study aims to understand the link between stress and heart health for people with PAD. If you participate, you will have different stress measuring methods evaluated. This may involve questionnaires, monitoring tools, or other assessments to understand your stress levels. Researchers will then follow your health over time to see what heart or limb events occur. The total duration of your participation and the frequency of visits would be explained in detail by the study team, but it will involve regular check-ups to track your health and stress levels.

Potential risks and benefits

Taking part in this study may offer the benefit of a more thorough health assessment and closer monitoring of your condition. While there are no direct medical treatments offered as part of this study, the information gained could lead to better ways of identifying and helping patients with PAD in the future. Potential risks are generally low, mainly involving the time commitment for appointments and any minor discomfort from assessment procedures. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen
Verified postcode
Essen, Germany· Recruiting

Common questions

What is Peripheral Arterial Disease (PAD)?

PAD is a condition where narrowed blood vessels reduce blood flow, usually to the legs and feet. It can cause pain, especially when walking, and increase risks for heart problems.

Why is stress important in PAD?

Stress can affect your heart and blood vessels, potentially making existing heart conditions like PAD worse. This study wants to find better ways to measure this link.

Will I receive new treatment in this study?

No, this study is about evaluating different ways to measure stress, not testing new treatments. Your current medical care will not change due to participating.

Who is funding this research?

The information provided doesn't specify the funding source. This is a good question to ask the study team.

How long will I need to be in the study?

The study aims to follow participants to see if stress relates to future heart events. The exact duration would be explained by the study team if you're eligible.

How to find out more

Julia Lortz, MD

julia.lortz@uk-essen.de +49201723-84995 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.