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OpenTrials
Completed

NCT Number: NCT02091427

Circadian Variation of Cardiac Troponin

Acute myocardial infarction (AMI) is defined by an increase and/or decrease in the concentration of cardiac troponin, with at least one value above the 99th percentile value of the reference population together with evidence of ischemia. An objective tool to determine the magnitude of the cardiac troponin change is the use of reference change values (RCV). The basis for this tool is that, for a change to be significant, the difference in serial results must be greater than the inherent variation in two test results. The inherent variation of a laboratory test result is composed of analytical and within-subject biological variation. An important requirement to use RCVs is that the concentrations of cardiac troponins fluctuate randomly around a homeostatic set point in cardio-healthy individuals. Verification of this important condition has never been performed, and violation of this condition would preclude the use of RCV's in clinical practice.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Center

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Individuals with no evidence of active cardiovascular disease

Exclusion criteria

  • History of acute myocardial infarction in the last year

Treatment and study plan

Primary outcomes

  1. cardiac troponins

    Time frame: measured every hour, total time 25h (08:30 day 1, till 09:30 day 2)

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 19, 2014
Registry last updated
Mar 3, 2015

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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