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Troponin Excretion in Urine in Patients With and Without Chronic Kidney Disease

Troponin Excretion in Urine in Patients With and Without Chronic Kidney Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04211610
Enrollment
131
Registered
2019-12-26
Start date
2020-01-01
Completion date
2023-12-31
Last updated
2024-01-17

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

Conditions

Chronic Kidney Diseases, Acute Myocardial Infarction

Brief summary

In this study, in order to better understand the mechanism of troponin clearance and the reason for elevated troponin levels in patients with CKD, we aim to evaluate quantitatively the excretion of troponin in the urine in patients with and without CKD, and with and without myocardial injury. We will compare urinary troponin levels with blood troponin levels in these patients. In addition, we will compare the levels of hs-cTnT and hs-cTnI in the patients' sera and urine.

Detailed description

The study population will be screened at the internal wards, the nephrology ward and clinic, and the intensive cardiac care unit (ICCU) of Soroka Medical Center. It will include patients who suffer from AMI, patients with CKD with and without any cardiac disease and patients with no known renal or cardiac disease. The following information and measurements will be collected: Demographics - age, sex, weight, height. Past medical history - specifically regarding renal and cardiac diseases and procedures. Measured variables in blood serum - troponin T, troponin I, creatinine, total protein, albumin, myoglobin Measured variables in urine - troponin T, troponin I, creatinine, total protein, albumin, microalbumin, β2-microglobulin Calculations - GFR (according to MDRD equation), troponin correction to creatinine (gr troponin per gr creatinine), troponin excretion ( ), urine albumin/creatinine ratio, urine protein/creatinine ratio.

Interventions

* Blood tests - hs-cTnT, hs-cTnI, complete metabolic panel including urea, creatinine, albumin and myoglobin * Urine tests - hs-cTnT, hs-cTnI, urea, creatinine, albumin, total protein, β2-microglobulin.

Sponsors

Soroka University Medical Center
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

1. Patients who are able to give informed consent. 2. Age ≥ 18

Exclusion criteria

1. Pregnant women 2. Patients after kidney transplantation. 3. Patients after heart transplantation. 4. Anuric patients.

Design outcomes

Primary

MeasureTime frameDescription
Troponin T in blood vs. urine1 yearQuantitative measurements of hs-cTnT in blood and urine
Troponin I in blood vs. urine1 yearQuantitative measurements of hs-cTnI in blood and urine

Secondary

MeasureTime frameDescription
Troponin excretion in urine compared to creatinine1 yearComparing urine troponin levels to urine creatinine, albumin, β2-microglobulin
Troponin excretion in urine compared to albumin1 yearComparing urine troponin levels to urine albumin
Troponin excretion in urine compared to β2-microglobulin1 yearComparing urine troponin levels to urine β2-microglobulin

Countries

Israel

Outcome results

None listed

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