RecruitingOBSERVATIONAL

Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery

This study focuses on people having heart valve surgery. Doctors often check for substances called 'cardiac biomarkers' (like troponin) in the blood to see if the heart has been damaged, for example, by a heart attack. However, sometimes these markers go up even when there isn't clear damage you can see on scans. This research wants to understand if these rises truly mean there's heart damage and how accurately different markers show this. By comparing different markers and visible damage, the study hopes to improve how doctors understand and treat patients after heart surgery, potentially influencing international guidelines on how heart damage is defined and diagnosed. It's about making sure the right heart problems are identified and treated effectively.

At a glance

Status

Recruiting

Sponsor

Jena University Hospital

Enrolment target

100

Start

05 Sep 2023

Estimated completion

31 Dec 2025

Cardiac Valve Disease

What is this study about?

When someone has heart surgery, especially for problems like a faulty heart valve, doctors keep a close eye on their heart. One way they do this is by checking for certain substances in the blood called 'cardiac biomarkers.' The most common ones are troponin I, troponin T, and CK-MB. These biomarkers are usually released into the bloodstream when heart muscle cells are damaged or die, which can happen during a heart attack.

However, it's not always straightforward. Sometimes these biomarkers go up after surgery, or even in other situations like after intense exercise or with certain health conditions, without there being clear signs of a heart attack that doctors can see on scans. This makes it tricky for doctors to know exactly what's happening to the heart, and whether a rise in biomarkers always means there's new, serious damage that needs immediate treatment.

This study aims to clear up this uncertainty. It wants to find out if increases in these biomarkers after heart valve surgery actually match up with heart damage that can be seen using special scans. It also wants to compare how the different biomarkers (troponin I, troponin T, and CK-MB) behave over time after surgery. The results could be very important for doctors worldwide, helping them to better understand what these biomarker levels mean, how to diagnose heart problems more accurately after surgery, and ultimately, how to give patients the best possible care.

Key takeaways

The study investigates how heart damage markers relate to visible heart damage after valve surgery.
It aims to compare different heart biomarkers like troponin and CK-MB.
Findings could improve how doctors diagnose heart problems after surgery.
Participation involves extra blood tests and heart scans (MRIs).
You must be an adult having single heart valve surgery, without active heart artery disease.
Your standard medical care will not be affected by joining or leaving the study.

Who may be eligible?

This study is looking for adults aged 18 or older who are scheduled to have surgery for a single heart valve problem, either aortic or mitral. To join, you'll need to understand the study and agree to take part by signing a consent form.

You cannot take part if you have a known problem with your heart's blood vessels (like blockages in your arteries, confirmed in the last six months). You also can't join if you have certain medical conditions or devices that prevent you from having an MRI scan, or if you have severe kidney problems. If you are pregnant or breastfeeding, you're also unable to participate.

It's important to know that if unexpected problems occur during or after your surgery that could cause heart damage or if your surgeon needs to do more than just the planned single valve repair, you might have to leave the study, as this would affect what the researchers are trying to measure.

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?
Are you scheduled for surgery on only one heart valve (aortic or mitral)?
Do you NOT have known blockages in your heart arteries (coronary artery disease)?
Can you safely have an MRI scan?
Are you NOT pregnant or breastfeeding?
Do you have good kidney function (not severely reduced)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, doctors will follow your journey from before your heart valve surgery through your recovery. They will take blood samples at specific times to measure the different heart biomarkers. You will also have additional heart scans, likely MRI, before and after your surgery, to look for any signs of heart damage. The study will mainly involve collecting information from these blood tests and scans, along with details about your surgery and recovery. You won't be given any new or experimental medications as part of this study.

Potential risks and benefits

Taking part in this study could help improve understanding of heart health after surgery, which may benefit future patients. For you directly, there might not be an immediate personal health benefit. The study involves extra blood tests and MRI scans, which carry their own small, known risks, such as discomfort from blood draws or, rarely, allergic reactions to MRI contrast if used. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Universitäts-Herzzentrum Freiburg • Bad Krozingen
Verified postcode
Freiburg im Breisgau, Germany· Recruiting
Universitätsklinikum Ulm
Verified postcode
Ulm, Germany· Recruiting
Universitätsklinikum Münster
Verified postcode
Münster, Germany· Recruiting
Universitätsklinikum Halle
Verified postcode
Halle, Germany· Recruiting
Universitätsklinikum Jena
Verified postcode
Jena, Germany· Recruiting

Common questions

What are cardiac biomarkers?

These are specific substances found in your blood that doctors can measure. Higher levels can be a sign that your heart muscle has been damaged.

Why is this study important for heart valve surgery patients?

It helps doctors understand if increases in these biomarkers after surgery truly mean there's heart damage and how to interpret these results better, leading to improved care.

Will I receive a special treatment if I join?

No, you will receive standard medical care for your heart valve surgery. The study mainly involves extra tests like blood samples and scans.

What's troponin?

Troponin is a type of protein found in heart muscle. When heart cells are damaged, troponin is released into the bloodstream, making it a key biomarker for heart injury.

Can I stop participating in the study at any time?

Yes, you have the right to withdraw from the study at any point, and your decision will not affect your medical care.

How to find out more

Tulio Caldonazo, Dr.

tulio.caldonazo@med.uni-jena.de +49 36419322953 Official trial record

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