To study the effect of renal clearance on the biological variation and the circadian rhythm of cardiac troponin.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Concentrations of cardiac troponin T and I over 24 hours, after one week, after
one month and after three months
Secondary outcome
Measures of:
* Basic clinical chemistry parameters to verify a non-disturbed day-night
rhythm; such as cortisol, creatine kinase and electrolyte concentrations
* Basic clinical chemistry, haematological and endocrinological parameters to
assess the variation of these parameters in subjects with diminished kidney
function
* 24 hour automatic blood pressure measurements
* Albumin concentration and hematocrit values, to correct for hydration status.
* Concentration of creatinine, to estimate the glomerular filtration rate.
* Urine concentrations of creatinine, electrolytes and cardiac markers.
Background summary
Cardiac troponin is the preferred biomarker for the diagnosis of acute
myocardial infarction. Whereas the diagnosis is based on an increase and/or
decrease in the concentrations of cardiac troponins with at least one value
above the 99th percentile value of the reference population together with the
evidence of ischemia, serial sampling is needed. A recent study by our group
showed a circadian rhythm in cardiac troponin levels. This circadian rhythm is
important regarding the interpretation of the serial cardiac troponin levels.
It is not clear whether this rhythm is present in subjects with renal
impairment. This study will assess the effect of renal clearance on the
circadian rhythm of cardiac troponins.
Study objective
To study the effect of renal clearance on the biological variation and the
circadian rhythm of cardiac troponin.
Study design
Observational study (with invasive measures) consisting of one wake- and sleep
cycle with a total duration of 26 hours. Participants will come back to the
laboratory for short visits after one week, one month and three months.
Study burden and risks
The risks associated with the proposed study are low. At the insertion site of
the intravenous catheter and venepuncture, a hematoma could occur.
Disadvantages of participating in this study for participants are the time
investment and the burden. Participants do also need to travel to the
university.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Individuals (age >18 years) with chronic kidney disease (CKD) stage 3 (eGFR 30*59 mL/min/1.73m2) and stage 4 (eGFR 15*29 mL/min/1.73m2) without dialysis and with no evidence of active cardiac disease (abscence of: angina pectoris, cardiomyopathy and myocarditis) (age >18 years) will be recruited to participate in our study.
Exclusion criteria
- acute myocardial infarction (AMI) in the last year.
- anaemia (Hb < 6.5 mmol/L)
- pulmonary embolism in the last six months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48734.068.14 |