Sponsor study identifier
observational
20
1 country
1
Study Start
August 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2016
Actual (reported)Study Completion
February 2016
Actual (reported)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. Knowledge of the variation in cardiac troponin levels over time in individuals in a normal rest state (not during an acute myocardial infarction), also called the biological variation, is important regarding the interpretation of the serial cardiac troponin levels. 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. Increased cTnI and cTnT concentrations are common in subjects with renal impairment. The mechanism of the elevated concentration of cTn in these subjects is still unclear. It is hypothesized that impaired renal clearance contributes to elevated levels of cTn. However, it is not clear whether renal function affects the biological variation and circadian rhythm of cTn. The monitoring of the biological variation and circadian rhythm of cTn in subjects with impaired renal function creates the opportunity to assess the effect of renal clearance on the circadian rhythm of cardiac troponins.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2014
Date type not reportedThis date has not been verified as actual or estimated.
August 5, 2014
Actual (reported)August 7, 2014
Actual (reported)January 2016
Actual (reported)February 2016
Actual (reported)Cardiac Troponins (cardiac troponin I (cTnI) and cardiac troponin T (cTnT))
up to three months
24-hour automatic blood pressure measurements (diastolic and systolic blood pressure)
total time 25 hours (first testday)
Urine concentrations of creatinine, electrolytes and cardiac markers
every 4 hours, total time 25 hours (first testday)
Individuals with chronic kidney disease (CKD) stage 3 and 4
Maastricht University Medical Center
Maastricht, Netherlands
Klinkenberg LJ, van Dijk JW, Tan FE, van Loon LJ, van Dieijen-Visser MP, Meex SJ. Circulating cardiac troponin T exhibits a diurnal rhythm. J Am Coll Cardiol. 2014 May 6;63(17):1788-95. doi: 10.1016/j.jacc.2014.01.040. Epub 2014 Feb 26.
Breidthardt T, van Doorn WPTM, van der Linden N, Diebold M, Wussler D, Danier I, Zimmermann T, Shrestha S, Kozhuharov N, Belkin M, Porta C, Strebel I, Michou E, Gualandro DM, Nowak A, Meex SJR, Mueller C. Diurnal Variations in Natriuretic Peptide Levels: Clinical Implications for the Diagnosis of Acute Heart Failure. Circ Heart Fail. 2022 Jun;15(6):e009165. doi: 10.1161/CIRCHEARTFAILURE.121.009165. Epub 2022 Jun 7.
Steven JR Meex, PhD
Maastricht University Medical Center
20 participants (actual enrollment reported by the registry).
First Submitted
August 5, 2014
First Posted
August 7, 2014
Study Start
August 2014
Date type not reportedThis date has not been verified as actual or estimated.
A study to learn more about how BAY3283142 moves into, through, and out of the body of healthy participants when taken together with atazanavir and to assess the proportion of BAY3283142 that reaches the blood when taken by mouth.
Contact the study team to confirm eligibility.
Primary Completion
January 2016
Actual (reported)Study Completion
February 2016
Actual (reported)Last Updated
February 18, 2016
Record last verified: 2015-04
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Source: ClinicalTrials.gov.
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