Influence of Renal Function on the Circadian Variation of Cardiac Troponin

Chronic Kidney Diseases Clinical Trial

Official title:

Influence of Renal Function on the Circadian Variation of Cardiac Troponin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02210897
• Other study ID #: METC 14-2-016
• Status: Completed
• Phase: N/A
• First received: August 5, 2014
• Last updated: February 17, 2016
• Start date: August 2014
• Est. completion date: February 2016

Study information

• Verified date: April 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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)

Study Design

N/A

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

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, 

References & Publications (1)

Klinkenberg LJ, van Dijk JW, Tan FE, van Loon LJ, van Dieijen-Visser MP, Meex SJ. Circulating cardiac troponin T exhibits a diurnal rhythm. J Am Coll Cardiol. 2014 May 6;63(17):1788-95. doi: 10.1016/j.jacc.2014.01.040. Epub 2014 Feb 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	24-hour automatic blood pressure measurements (diastolic and systolic blood pressure)		total time 25 hours (first testday)	No
Other	Urine concentrations of creatinine, electrolytes and cardiac markers		every 4 hours, total time 25 hours (first testday)	No
Primary	Cardiac Troponins (cardiac troponin I (cTnI) and cardiac troponin T (cTnT))		up to three months	No