All studies
RecruitingNAINTERVENTIONAL

Liquid Biopsy System Intracoronary Blood Sampling and Analysis to Characterise Disease Biomarkers in Patients With Coronary Disease

This important study, funded by PlaqueTec and organised by Papworth Trials Unit Collaboration, is designed to help us better understand and treat coronary artery disease. Researchers are testing a new device called a Liquid Biopsy System (LBS). This device collects tiny blood samples directly from inside the heart's arteries. By analysing these samples, the team hopes to identify specific markers of the disease. Finding these 'biomarkers' will fill important gaps in our knowledge and could lead to the development of treatments that are much more targeted and effective for individual patients with coronary artery disease.

At a glance

Status
Recruiting
Phase
NA
Sponsor
PlaqueTec Ltd
Enrolment target
300
Start
14 Sep 2023
Estimated completion
01 Feb 2028

What is this study about?

Heart disease, specifically coronary artery disease, happens when the blood vessels that supply your heart become narrowed or blocked. This can lead to serious health problems. Currently, treatments often work for many people, but doctors are always looking for ways to make them even better and more personal to each patient.

This study is testing a new tool, called a Liquid Biopsy System (LBS), which is a small device designed to collect tiny blood samples directly from inside the blood vessels of your heart. Imagine being able to get a very specific picture of what's happening right where the disease is. That's what this device aims to do.

The main goal is to see how well this new device works and how useful it is for gathering different information (called 'biomolecules') from the blood inside your coronary arteries. By carefully studying these blood samples, researchers hope to discover important signs or 'biomarkers' of the disease. This new knowledge could help doctors develop medicines and treatments that are much more tailored to each person's unique condition, leading to more effective care.

Key takeaways

  • This study aims to discover new ways to treat coronary artery disease.
  • It uses a new device to collect blood samples directly from heart arteries.
  • The goal is to find 'biomarkers' for more personalised treatments.
  • Participation happens during an already planned heart procedure.
  • You must have diagnosed coronary artery disease to be eligible.
  • The research won't change your current medical care.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and agree to participate. You must also have been diagnosed with a type of heart disease called coronary artery disease that is narrowing your heart arteries. This means you will already be scheduled for a procedure such as an angiogram (a special x-ray of your heart arteries) or a procedure to unblock arteries (called a PCI).

There are also certain health conditions that would prevent you from taking part. For example, you cannot have had a heart attack in the last 30 days, or have severe kidney failure. Other reasons include having very low blood pressure, serious heart rhythm problems, severe heart failure, or an active infection.

The doctors will also check your heart arteries very carefully during the angiogram. There are specific features of your arteries, like their shape or if they have had previous treatments, that might mean the device can't be used safely or effectively, and therefore you wouldn't be able to join the study.

Quick self-check
  • Are you 18 years old or older?
  • Do you have coronary artery disease and are scheduled for an angiogram or similar heart procedure?
  • Have you *not* had a heart attack in the last 30 days?
  • Do you *not* have severe kidney failure or active serious infections?
  • Are you able to provide informed consent?
  • Are you *not* pregnant?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, the main part of your involvement will happen during your scheduled heart procedure (like an angiogram or PCI). During this procedure, the new Liquid Biopsy System device will be carefully introduced into your heart artery to collect tiny blood samples. This will be done by the heart specialist (cardiologist) who already treats you. The procedure is typically no longer than your standard planned procedure, but involves the additional specific collection device. You will not need to make extra visits solely for this study, as it piggybacks onto your planned clinical care. The research team will collect and analyse the blood samples, but you will not need to do anything further yourself. There are no additional medications specifically for this study.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. For you, a potential benefit is contributing to new knowledge that could lead to improved treatments for coronary artery disease in the future. The risks directly related to the study procedure are thought to be very low, as the blood sampling device is used during a procedure you are already scheduled to have. The doctors are highly experienced in these types of heart procedures. We will discuss any potential risks thoroughly with you before you agree to participate. You are also free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

  • Royal Bournemouth Hospital
    Bournemouth, United Kingdom· Recruiting
  • Bristol Heart Institute
    Bristol, United Kingdom· Recruiting
  • Royal Papworth Hospital
    Cambridge, United Kingdom· Recruiting
  • Norfolk and Norwich Hospital
    Norwich, United Kingdom· Recruiting

Common questions

What is coronary artery disease?

It's a common heart condition where the arteries supplying blood to your heart become narrowed, leading to problems like chest pain or heart attacks.

What is a 'liquid biopsy'?

It's a way of collecting blood samples to look for signs of disease, in this case, directly from within your heart arteries to get very specific information.

Will I have extra procedures if I join?

No, the blood sampling will be done during a heart procedure (like an angiogram) that you are already scheduled to have.

Will this study change my regular treatment?

No, this study is about collecting information. It will not change the standard treatment plan your doctor has for you.

Why is this research important?

It could help doctors understand heart disease better and develop more personalised and effective treatments for patients in the future.

How to find out more

Clinical Project Manager

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 "Liquid Biopsy System Intracoronary Blood Sampling and Analys…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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