Cardiac Biomarkers for Heart Surgery Damage Assessment
Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
Recruiting
Observational Study
Cardiac Valve Disease
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
100 (estimated)
Sponsor
Jena University Hospital · Other
Who this trial is looking for
This trial is looking for adults who need aortic or mitral valve surgery to help researchers understand how certain heart proteins relate to heart damage after surgery. Participants will provide consent and undergo assessments related to their surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I need isolated aortic or mitral valve surgery
I am 18 years or older
I have given written informed consent
You may not be able to join if
I have had coronary artery disease in the last 6 months
I am allergic to gadolinium
I have a cochlear implant
I have deep brain stimulation
I cannot have an MRI for personal reasons (e.g., claustrophobia)
I have significantly reduced kidney function (GFR < 30ml/min)
I have had complications during surgery that may harm my heart
I am pregnant or breastfeeding
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The aim of the study is to clarify whether the perioperative release of the cardiac biomarkers troponin I, troponin T and CK-MB consistently correlate with visualizable myocardial damage, and to what extent these biomarkers are comparable by means of their kinetics and dynamics.
Due to the uncertainty regarding the validity of cardiac biomarkers in the diagnosis of myocardial infarction, the answ…
The aim of the study is to clarify whether the perioperative release of the cardiac biomarkers troponin I, troponin T and CK-MB consistently correlate with visualizable myocardial damage, and to what extent these biomarkers are comparable by means of their kinetics and dynamics.
Due to the uncertainty regarding the validity of cardiac biomarkers in the diagnosis of myocardial infarction, the answer to these questions could have a considerable influence on internationally valid guidelines and definitions. International studies, especially in the field of coronary surgery and coronary artery disease treatment refer to these definitions, in particular, the adequate treatment of affected patients is directly dependent on them.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Indication for isolated aortic or mitral valve surgery
* Written informed consent
* Age ≥ 18 years
Exclusion Criteria:
* Presence of coronary artery disease (excluded within the last 6 months)
* Allergy to gadolinium
* Cochlear implant
* Deep brain stimulation
* Individual f…
Inclusion Criteria:
* Indication for isolated aortic or mitral valve surgery
* Written informed consent
* Age ≥ 18 years
Exclusion Criteria:
* Presence of coronary artery disease (excluded within the last 6 months)
* Allergy to gadolinium
* Cochlear implant
* Deep brain stimulation
* Individual factors excluding the performance of an MRI (e.g. claustrophobia of the patient)
* Significantly reduced renal function (GFR \< 30ml/min)
* Perioperative complications that may lead to myocardial damage (discontinuation of the study for the patient and exclusion from the analysis after primary study inclusion)
* Need for extension of surgery (additional procedures on other heart valves, aorta, myocardium, or similar; exclusion after primary study inclusion possible)
* Pregnancy or lactation
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