Circadian Variation of Cardiac Troponin

Healthy Individuals Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091427
• Other study ID #: METC 12-2-074
• Status: Completed
• Phase: N/A
• First received: March 18, 2014
• Last updated: March 2, 2015
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals with no evidence of active cardiovascular disease

Exclusion Criteria:

• History of acute myocardial infarction in the last year

Study Design

N/A

Related Conditions & MeSH terms

• Healthy Individuals

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac troponins		measured every hour, total time 25h (08:30 day 1, till 09:30 day 2)	No