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OpenTrials
Completed

NCT Number: NCT02210897

Influence of Renal Function on the Circadian Variation of Cardiac Troponin

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CKD stage 3 or 4
  • No dialysis
  • No evidence of active, acute cardiovascular disease

Exclusion criteria

  • History of acute myocardial infarction in the last year
  • History of pulmonary embolism in the last six months
  • Anemia (Hb < 6.5 mmol/L)

Treatment and study plan

Primary outcomes

  1. Cardiac Troponins (cardiac troponin I (cTnI) and cardiac troponin T (cTnT))

    Time frame: up to three months

Other outcomes

  1. 24-hour automatic blood pressure measurements (diastolic and systolic blood pressure)

    Time frame: total time 25 hours (first testday)

  2. Urine concentrations of creatinine, electrolytes and cardiac markers

    Time frame: every 4 hours, total time 25 hours (first testday)

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 7, 2014
Registry last updated
Feb 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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