RecruitingOBSERVATIONAL

Clinical Study for the Investigation and Validation of a Therapy Procedure for the Adjustment of Risk Factors in Patients With Coronary Heart Disease by Means of Digital Therapy Control

This study is looking into a new digital tool called iATROS, which can be used on your smartphone. It's designed for people who have coronary heart disease (CHD), also known as heart artery disease. The main goal is to check how well this app helps patients keep their heart disease risk factors under control compared to the usual care they receive. We also want to understand how the app works and how it can be improved, especially in helping target health goals for patients. Additionally, the study will explore how effective using smartphones is for managing and preventing further heart problems in people with CHD.

At a glance

Status

Recruiting

Sponsor

iATROS GmbH

Enrolment target

1,000

Start

05 Oct 2023

Estimated completion

01 Oct 2026

Coronary Artery Disease Cardiovascular Diseases Coronary Heart Disease Ischemic Heart Disease

What is this study about?

This study is about exploring a new way to help people who have coronary heart disease (CHD), a condition where the main blood vessels supplying the heart get narrowed or blocked. This is often called heart artery disease. The study is particularly interested in whether a new digital app called iATROS can help you manage your health better.

The iATROS app is designed to help you keep track of things that can increase your risk of heart problems, like blood pressure or cholesterol levels. The research team wants to compare how well people using this app manage these risk factors against those receiving the usual care from their doctors. They also want to understand how the app’s features work in practice and gather ideas to make it even better for helping patients.

Ultimately, this study will help us understand if using digital tools, like smartphone apps, can be a useful and effective way for people with heart disease to manage their condition and improve their long-term health. It’s part of a bigger effort to use technology to make healthcare more convenient and personalised.

Key takeaways

This study tests a new smartphone app for heart disease management.
It aims to help control risk factors like blood pressure and cholesterol.
Participation involves using the iATROS app regularly.
Compares digital management to standard medical care.
Requires participants to own and use a smartphone.
You can leave the study at any time.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have been diagnosed with a type of heart artery disease (also known as ischemic heart disease or coronary heart disease). This includes if you've had a heart attack in the past, or if you've had procedures like a stent, angioplasty, or bypass surgery for your heart.

You also need to own a smartphone and be able to use the iATROS app on it. This means you should be physically and mentally able to install and use apps on your phone. You must also be insured with one of the collaborating insurance companies that are working with the study.

There are also some reasons why you might not be able to join. For example, if you don't use a smartphone, can't use apps, or if you have another serious illness that significantly shortens your life expectancy (less than 2 years). Pregnant or breastfeeding individuals, people with severe dementia, or those already in another iATROS health program or a different clinical study might also not be able to participate. If you have other health conditions that would make it difficult to set clear health goals in the study, you might also be excluded.

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 heart artery disease (CHD) or had a heart attack, stent, angioplasty, or bypass surgery?
Do you own a smartphone and can you use apps on it comfortably?
Are you able to speak and understand the study language?
Are you insured with one of the study's partner insurance companies?

Answer every question to see your result.

What does participation involve?

We don't have all the details yet, but if you join this study, you would be asked to use the iATROS app on your smartphone regularly. This app helps you manage your heart disease and its risk factors.

Your progress will be compared to people receiving standard medical care. The study will involve collecting information about your health and how you use the app. This could include checking your health measurements and other data collected through the app. There will likely be regular check-ins or assessments to monitor your progress.

The study aims to see how well the app works in the long run. The exact number of visits, specific assessments, or the overall duration of your involvement are not detailed yet, but all these aspects would be clearly explained to you before you agree to participate.

Potential risks and benefits

Taking part in this study might offer some potential benefits, such as gaining access to a new digital tool (iATROS app) that could help you manage your heart disease risk factors more effectively. This could lead to a better understanding of your health and potentially improve your heart health outcomes. However, as with any study, there could be some risks. These might include the time commitment required, or the possibility that the app doesn't work as well for you as hoped. There's also the chance of technical issues with the app or your smartphone. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Klinikum der Ludwig-Maximilians-Universität München (Klinikum der Universität München), Medizinische Klinik und Poliklinik I
Verified postcode
Munich, Germany· Recruiting

Common questions

What is coronary heart disease?

Coronary heart disease (CHD) is when the blood vessels that supply your heart become narrowed or blocked, often due to a build-up of fatty substances. This can lead to chest pain, heart attacks, and other serious heart problems.

What is the iATROS app?

The iATROS app is a digital tool for smartphones designed to help people with heart disease manage their health. It aims to help track and adjust risk factors linked to their condition.

Do I need my own smartphone to join?

Yes, you need to own a smartphone and be able to use it, including installing and using apps like iATROS.

Will this replace my usual doctor's care?

No, this study is comparing the app to standard medical care. The app is a tool that works alongside your doctor's care, not instead of it.

What are 'risk factors' for heart disease?

Risk factors are things that can increase your chance of developing or worsening heart disease, such as high blood pressure, high cholesterol, diabetes, smoking, and lack of exercise.

How to find out more

Paul Weyh, M. Sc.

paul.weyh@i-atros.com +49 176 856 23 142 Official trial record

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