Clinical Trials Directory

Trials / Completed

CompletedNCT02091427

Circadian Variation of Cardiac Troponin

Status
Completed
Phase
Study type
Observational
Enrollment
24 (actual)
Sponsor
Maastricht University Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Timeline

Start date
2013-01-01
Primary completion
2014-06-01
Completion
2014-12-01
First posted
2014-03-19
Last updated
2015-03-03

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT02091427. Inclusion in this directory is not an endorsement.