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Study of High Sensitive Troponin-I Level in End-stage Renal Disease Patients Receiving Hemodialysis

Study of High Sensitive Troponin-I Level in End-stage Renal Disease Patients Receiving Hemodialysis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02572466
Enrollment
207
Registered
2015-10-09
Start date
2015-02-28
Completion date
2015-11-30
Last updated
2016-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage Renal Disease

Keywords

high-sensitive troponin-I, End-stage renal disease, hemodialysis

Brief summary

This study objective is to compare the high sensitive troponin-I level in end-stage renal disease patients received hemodialysis without acute cardiovascular event with healthy population. The investigators also determine the effect of hemodialysis on troponin I level as the secondary objective.

Detailed description

Human cardiac Troponin I (cTnI) is an composition of Troponin which is found in heart muscle cells. Molecular weight of cTnI is 23,875 Dalton consisting of 209 amino acids. \[1,2\] The cTnI have been used in the diagnosis of acute myocardial infarction(AMI). \[3,4,5\] According to ESC / ACCF / AHA / WHF, diagnosis of acute myocardial infarction rely on the data from clinical symptoms, Electrocardiogram (EKG) changes in the specific pattern, such as ST-segment elevation / depression, new left bundle branch block, and cardiac biomarker level rise over the 99th percentile upper reference limit, which makes the cTnI level was used to help in making diagnosis for patient coming with symptoms of angina in emergency room. The current cTnI detecting test has developed more and more high sensitive(called high-sensitive troponin-I; hsTnI) which can detected in the range 10-50,000 pg / ml (ng / L) \[6\], and it can detected cTnI level even in normal people unlike cTnI, which only reported positive or negative or lower than the limit of detection. Due to ARCHITECT stat High sensitive Troponin-I (Abbott diagnostic) capabilities, hsTnI level can be detected in normal people up to 96 percent.\[7\] The reference range of hsTnI which has been researched by Apple FS, et al.(2012) studying the 19 types of cardiac troponin I and T measurement was established. The 99th percentile values for general healthy population without hypertension, diabetes, kidney disease and myocardial infarction, aged 18-64 years was 36 ng / L in men (N = 272), 15 ng / L in women (N = 252) \[7\]. However, research to find the reference of hsTnI in some groups , especially in patients with kidney disease is still limited and the diagnosis of acute myocardial infarction also use the 99th percentile as the reference source which was researched in healthy population\[7\] which makes it difficult to interpret. Sometimes doctors may concluded that patients with rising hsTnI because of kidney disease. According to the research in the next section, there are both support and against in this idea. Therefore, the researchers aim to study hsTnI in patients with end-stage renal disease received hemodialysis compare with normal population.

Interventions

OTHERHemodialysis

ESRD group received long-term hemodialysis

Sponsors

Chulalongkorn University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Aged 18 years or more. * was diagnosed as End-stage renal disease for more than one year. * Attend hemodialysis 3 times a week consistently for more than 6 months. * Hemodialysis with Kt/V \> 1.2 * No urine output or is less than 500 ml per day. * No symptoms of myocardial infarction Or were hospitalized with the similar diagnosis during the two weeks.

Exclusion criteria

* Could not complete hemodialysis, or Kt / V \<1.2 * Has symptoms of myocardial infarction while receiving dialysis * Has the abnormal symptom (fever, chill, low BP) While receiving dialys

Design outcomes

Primary

MeasureTime frameDescription
High Sensitive Troponin-I in ESRD group vs Control group10 monthsESRD group * Measure the High Sensitive Troponin-I level before the hemodialysis session Control group * Measure the High Sensitive Troponin-I as an additional test to their follow up blood check.

Secondary

MeasureTime frameDescription
High Sensitive Troponin-I in pre-hemodialysis vs post-hemodialysis4 hoursMeasure the High Sensitive Troponin-I level before the hemodialysis session comparing to the level after the hemodialysis session.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026