Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06066970 |
| Other study ID # |
ZKSJ0156 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 5, 2023 |
| Est. completion date |
March 2025 |
Study information
| Verified date |
September 2023 |
| Source |
Jena University Hospital |
| Contact |
Ulrich Schneider, Dr. |
| Phone |
+49 3641 |
| Email |
ulrich.schneider[@]med.uni-jena.de |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
In the course of a myocardial infarction, the death of cardiomyocytes leads to the release of
specific cardiac biomarkers (CK-MB, troponin I and T). Since there is a general risk of
perioperative infarction in cardiac surgery, the standard monitoring includes appropriate
diagnostics. These are based on clinical symptoms, ECG, imaging (echocardiography or coronary
angiography) and, in particular, the elevation of these cardiac biomarkers. Recently, the
latter have been regularly moved into the foreground as the sole indicators of perioperative
myocardial infarction, and first definitions allow the diagnosis solely based on troponin or
CK-MB elevation.
However, biomarker elevations may not be accompanied by an image-morphologically detectable
perfusion defect (myocardial infarction). Such phenomena have been described outside of
cardiac surgery, for example, in marathon runners4, but also due to comorbidities such as
renal insufficiency or neurological diseases. Even in patients undergoing cardiac surgery
without coronary artery disease (e.g., isolated valve surgery), biomarker elevations up to
the infarct-defining range are regularly observed. Whether in the latter case the
perioperative routinely observed troponin or CK-MB elevation are indeed related to
surgery-induced chronic perfusion disturbance has not yet been investigated.
To date, there is no study that quantitatively correlates purely perioperatively induced
ischemic damage with the release of cardiac biomarkers. In addition, the three most commonly
used biomarkers for perioperative infarct diagnosis differ considerably in their temporal
release and release dynamics. Moreover, a direct comparison of all three parameters has never
been performed so far.
Therefore, the aim of this study is to quantify and compare the release of troponin T, I and
CK/CK-MB in the postoperative course in patients without relevant coronary artery disease
undergoing elective isolated heart valve surgery. These findings will subsequently be
correlated with classical diagnostics (clinic, ECG, echocardiography) and image morphological
quantification of perioperatively induced myocardial damage by magnetic resonance imaging
(LGE-cMRI).
