Circadian Variation of Cardiac Troponin

Completed

• Conditions: Healthy Individuals

• Registration Number: NCT02091427
• Lead Sponsor: Maastricht University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-18
• Study First Posted: 2014-03-19
• Primary Completion: 2014-06
• Study Completion: 2014-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-02
• Last Update Posted: 2015-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Individuals with no evidence of active cardiovascular disease

Exclusion Criteria

• History of acute myocardial infarction in the last year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cardiac troponins	measured every hour, total time 25h (08:30 day 1, till 09:30 day 2)

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands