Clincosm LogoSign in Get a demo

Influence of Renal Function on the Circadian Variation of Cardiac Troponin

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02210897
Collaborator
(none)
20
Enrollment
1
Location
18
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Official Title:
    Influence of Renal Function on the Circadian Variation of Cardiac Troponin
    Study Start Date :
    Aug 1, 2014
    Actual Primary Completion Date :
    Jan 1, 2016
    Actual Study Completion Date :
    Feb 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Cardiac Troponins (cardiac troponin I (cTnI) and cardiac troponin T (cTnT)) [up to three months]

    Other Outcome Measures

    1. 24-hour automatic blood pressure measurements (diastolic and systolic blood pressure) [total time 25 hours (first testday)]

    2. Urine concentrations of creatinine, electrolytes and cardiac markers [every 4 hours, total time 25 hours (first testday)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maastricht University Medical Center Maastricht Netherlands

    Sponsors and Collaborators

    • Maastricht University Medical Center

    Investigators

    • Principal Investigator: Steven JR Meex, PhD, Maastricht University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Maastricht University Medical Center
    ClinicalTrials.gov Identifier:
    NCT02210897
    Other Study ID Numbers:
    • METC 14-2-016
    First Posted:
    Aug 7, 2014
    Last Update Posted:
    Feb 18, 2016
    Last Verified:
    Apr 1, 2015
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic

    Study Results

    No Results Posted as of Feb 18, 2016