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RecruitingNAINTERVENTIONAL

Clinical Value and Cost-effectiveness of a Personalized Prevention Program (PPP) in Patients With High Risk Stable CHD

This research study is for people who have stable coronary heart disease (CHD), a condition where the blood vessels supplying the heart are narrowed. The main goal is to find out if a special 'personalised prevention program' (PPP) can help reduce serious heart events like heart attacks or heart failure compared to the care people usually receive. Researchers also want to see if this new program is cost-effective and how well certain tests can predict who is most at risk. The study involves two parts: first, screening many people with CHD to identify those at high risk, and then, a smaller group of high-risk individuals will either receive the personalised program or continue with their usual care. Researchers will compare outcomes between these two groups.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Tampere University
Enrolment target
12,000
Start
01 Feb 2023
Estimated completion
01 Dec 2026

What is this study about?

This study is designed to help people with stable coronary heart disease (CHD), which means they have narrowing of the arteries supplying the heart, but their condition isn't rapidly getting worse. The researchers are exploring a new approach called a 'Personalised Prevention Program' (PPP). Think of it like a tailor-made plan for your heart health, rather than a one-size-fits-all approach.

The study has two main steps. First, they will look at a large number of people with stable CHD to understand who is most likely to have future heart problems. They'll use special tests (called biomarkers) to help with this. The second step involves a smaller group of those identified as high-risk. These individuals will be split into two groups: one will follow the new Personalised Prevention Program, and the other will continue with the standard care they would normally receive from their doctors. The main idea is to see if the personalised program can do a better job at preventing serious heart issues like heart attacks or heart failure.

Ultimately, the team wants to learn if this personalised approach is not only effective in keeping people healthier but also if it makes good sense from a cost point of view for the NHS. They will also be studying how lifestyle changes, like diet and exercise, affect people's health and how best to advise people on these changes using special tools.

Key takeaways

  • This study aims to find better ways to prevent heart problems in people with stable heart disease.
  • It tests a 'personalised prevention program' against usual care to see which is more effective.
  • Researchers also want to check the value for money of this new program.
  • Special blood tests will be used to help identify people at higher risk of heart issues.
  • If you join, you might receive tailored advice on your heart health, including diet and exercise.
  • Participation involves appointments, possibly blood tests, and using a smartphone app.

Who may be eligible?

To be considered for this study, you generally need to be between 30 and 80 years old. You must have stable coronary heart disease, which means either you've had a narrowing in your heart arteries found in a scan in the last year, or you had a heart attack (Type I or II) in the past year.

There are certain situations that would prevent you from joining. For example, if you've recently been in hospital for a heart attack, stroke, or heart failure within the last month, you'd need to wait until a month after that event. Also, if you have severe heart failure (NYHA class III-IV), uncontrolled irregular heartbeats, severe kidney disease requiring dialysis, or other serious illnesses that might shorten your life, you wouldn't be able to participate.

Additionally, if you have conditions that make it very difficult to exercise, like severe arthritis or certain nerve or bone conditions, you might not be suitable. Lastly, you need to be willing and able to attend all study appointments, follow the study procedures, and use a smartphone app.

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.

  1. Are you between 30 and 80 years old?
  2. Do you have stable coronary heart disease confirmed by an angiogram/CT in the last year, or a heart attack (Type I or II) in the last year?
  3. Have you been free from a recent heart attack, stroke, or heart failure hospitalisation for at least one month?
  4. Can you attend all study appointments and use a smartphone app?
  5. Are you able to exercise without severe physical limitations?
Answer every question to see your result.

What does participation involve?

If you join this study, it would involve a number of appointments over a period of time. You would first be part of a larger screening phase. If you're identified as high-risk, you might then be asked to join the second part of the study, where you'd be randomly assigned to either receive the Personalised Prevention Program or usual care. The Personalised Prevention Program might involve guidance on diet and exercise, potentially using a special tool to help design your exercise plan, and a smartphone app to help track your progress. Researchers will collect information through questionnaires, blood tests, and potentially other health assessments to see how you're doing. The full duration of your involvement isn't specified but typically these studies involve follow-ups over several years.

Potential risks and benefits

Taking part in this study could offer several potential benefits. If you are in the personalised prevention group, you might receive extra support and tailored advice on managing your heart health, which could lead to a lower risk of future heart problems. You'd also contribute to important research that could improve care for many others with heart disease. As with any study, there could be some risks, such as potential discomfort from blood tests or time commitment for appointments. It's important to remember that you can stop being part of the study at any time, for any reason, without it affecting your usual medical care.

Locations (26)

  • Helsinki University Hospital
    Verified postcode
    Helsinki, Finland· Recruiting
  • Mehiläinen
    Verified postcode
    Helsinki, Finland· Recruiting
  • Kuopio University Hospital
    Verified postcode
    Kuopio, Finland· Not yet recruiting
  • Oulu University Hospital
    Verified postcode
    Oulu, Finland· Recruiting
  • Klinik am See
    Verified postcode
    Berlin, Germany· Not yet recruiting
  • CCV-MVZ
    Verified postcode
    Frankfurt, Germany· Withdrawn
  • Heidelberg University
    Verified postcode
    Mannheim, Germany· Not yet recruiting
  • Technise Universität Munchen
    Verified postcode
    München, Germany· Not yet recruiting
  • Herzklinik Ulm
    Verified postcode
    Ulm, Germany· Not yet recruiting
  • Hellenic Red Cross Hospital
    Verified postcode
    Athens, Greece· Not yet recruiting
  • Konstantopoulio Hospital
    Verified postcode
    Athens, Greece· Not yet recruiting
  • Sismanoglion Hospital
    Verified postcode
    Athens, Greece· Not yet recruiting

Common questions

What is 'Coronary Heart Disease'?

It's a condition where the major blood vessels that supply your heart become narrowed, often due to a build-up of fatty substances. This can reduce blood flow to the heart.

What does 'personalised prevention program' mean?

It's a health plan created specifically for you, based on your individual risk factors, to help prevent future heart problems, rather than a general programme for everyone.

Will I get paid for participating?

The study information doesn't mention payment. It's best to ask the study team directly about any compensation for your time or travel expenses.

What are 'biomarkers'?

These are naturally occurring molecules, such as proteins, which can be measured in your blood and used to indicate a disease, infection, or predict health risks.

Do I have to use a smartphone?

Yes, the study mentions that participants need to be willing to use a smartphone application as part of the study procedures.

How to find out more

Hanna Marttila, MSc

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

Interested in taking part?

Register your interest

Share your details and the research team for "Clinical Value and Cost-effectiveness of a Personalized Prev…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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