Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05779202 |
| Other study ID # |
KYMA |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2023 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
University Hospital Heidelberg |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The objective of this study is to evaluate acute changes of cardiac troponin (and other
cardiac biomarkers) and mid-term biovariability in patients with cardiomyopathy associated
with chronic skeletal muscle disease. The specific aims of the study are:
Firstly, to evaluate the feasibility of the ESC 0/1 hour protocol for rule-in and rule-out of
a non-ST-segment elevation acute coronary syndrome (NSTE-ACS).
Secondly, a) to determine reference change values (RCV) to characterize physiological
biovariability, b) to differentiate acute from chronic high-sensitivity cardiac troponin T
(hs-cTnT) elevations.
Description:
In patients with skeletal muscle dystrophy, cardiac involvement is one of the limiting
factors regarding mortality. Early detection of a dystrophy-associated cardiomyopathy is
important, as heart failure therapy can slow adverse cardiac remodeling and alleviate heart
failure symptoms. Cardiac biomarkers, especially high-sensitivity cardiac Troponin T
(hs-cTnT) and to a lesser extent, high-sensitivity cardiac Troponin I (hs-cTnI), are
chronically elevated in diseases with underlying structural heart disease. However, there is
no reliable data on whether changes in the concentration of cardiac Troponin T or I are
suitable for monitoring the cardiac disease progression. This can lead to delayed diagnosis
and treatment of a relevant deterioration of the disease or even acute heart muscle damage in
the context of acute myocardial infarction, pulmonary embolism, and myocarditis. Due to
insufficient clinical data, the feasibility and safety of the ESC 0/1-hour protocol according
to the ESC guidelines for the diagnosis of acute myocardial infarction in this patient
population are uncertain. Furthermore, it is necessary to determine the normal biovariability
of high-sensitivity cardiac Troponin T (hs-cTnT) and high-sensitivity cardiac Troponin I
(hs-cTnI) to differentiate physiological concentration fluctuations of these cardiac
biomarkers in this patient population from changes that represent an improvement or
deterioration of heart function. Routine blood samples that will be collected at
presentation, a second blood sample for study purposes will be collected after 1 hour for the
first index visit. On the routine follow-up visit, 20 ml of blood will be collected for
storage in addition to the routine blood test. Blood samples will be obtained by standard
venous blood sampling. If venipuncture is unsuccessful or considered harmful by the patient
and a suitable peripheral venous catheter is available, the venous catheter may be used for
blood sampling to minimize damage. Assessment of parameters includes demographics and
clinical characteristics (symptoms, history, medication, vital signs, risk scores etc.) and
laboratory values with special focus on findings related to myocardial injury as indicated by
high sensitivity cardiac troponin T (hs-cTnT) and hs-cTnI. Moreover, the laboratory panel
comprises other cardiac biomarkers, electrolytes, renal (creatine, glomerular filtration
rate) and liver function (GOT, GPT, LDH), C-reactive protein, D-dimer etc.
