Actively Recruiting

Age: 18Years +
All Genders
ID06066970

Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery

Led by Jena University Hospital · Updated on 2025-09-26

100

Participants Needed

5

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to understand how the release of specific heart-related proteins, called cardiac biomarkers (troponin I, troponin T, and CK-MB), relates to actual heart muscle damage in patients undergoing heart valve surgery. The study focuses on patients without significant coronary artery disease and seeks to clarify how these biomarkers compare in their timing and levels after surgery. Findings may influence international guidelines on diagnosing heart damage after cardiac procedures. The study observes patients having isolated aortic or mitral valve surgery and measures the release of the three cardiac biomarkers during the recovery period. It compares these biomarker levels with traditional diagnostic methods like clinical symptoms, ECG, echocardiography, and advanced heart imaging using magnetic resonance imaging (LGE-cMRI). The imaging is done before surgery and five days afterward to detect any heart muscle injury. Participants will undergo clinical evaluations, ECGs, echocardiography, and blood tests to track biomarker levels around the surgery. They will also have magnetic resonance imaging before surgery and at five days post-surgery to visualize heart muscle damage. Researchers will analyze how the biomarker releases correlate with imaging findings and clinical assessments. The study helps improve understanding of heart injury detection during and after valve surgery and lasts through the immediate postoperative period.

CONDITIONS

Brief Title

Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Indication for isolated aortic or mitral valve surgery
  • Written informed consent
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Presence of coronary artery disease diagnosed within the last 6 months
  • Allergy to gadolinium
  • Having a cochlear implant
  • Having deep brain stimulation device
  • Any condition preventing MRI (e.g., claustrophobia)
  • Significantly reduced kidney function (GFR less than 30 ml/min)
  • Perioperative complications causing heart damage leading to study discontinuation
  • Need for additional heart surgery beyond isolated valve procedure
  • Pregnancy or breastfeeding

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Hospital stay duration (varies per participant)

Participants undergo elective isolated heart valve surgery followed by standard post-operative monitoring including clinical assessments, ECG, and echocardiography.

1 surgery visit and several in-hospital assessments

Diagnostic Evaluation

Duration - Pre-surgery and up to 5 days post-surgery

Participants have cardiac biomarkers measured and undergo magnetic resonance imaging to quantify myocardial damage related to surgery.

2 visits (pre-surgery and 5 days post-surgery)

Post-operative Follow-up

Duration - Up to 5 days post-surgery

Participants are observed for changes in biomarkers and clinical status following surgery to assess recovery and myocardial damage.

Additional assessments during hospital stay

Trial Site Locations

Total: 5 locations

1

Universitäts-Herzzentrum Freiburg • Bad Krozingen

Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106

Actively Recruiting

2

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany, 89081

Actively Recruiting

3

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany, 48149

Actively Recruiting

4

Universitätsklinikum Halle

Halle, Saxony-Anhalt, Germany, 06120

Actively Recruiting

5

Universitätsklinikum Jena

Jena, Thuringia, Germany, 07747

Actively Recruiting

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Research Team

T

Tulio Caldonazo, Dr.

M

Marcus Winter

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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