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Completed

NCT Number: NCT04211610

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

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.

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Key information

Conditions

Chronic Kidney Diseases Acute Myocardial Infarction Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Soroka Medical Center

Beersheba, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnant women
  • Patients after kidney transplantation.
  • Patients after heart transplantation.
  • Anuric patients.

Treatment and study plan

Blood and urine sampling

Diagnostic Test
  • 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.

Primary outcomes

  1. Troponin T in blood vs. urine

    Time frame: 1 year

    Quantitative measurements of hs-cTnT in blood and urine

  2. Troponin I in blood vs. urine

    Time frame: 1 year

    Quantitative measurements of hs-cTnI in blood and urine

Secondary outcomes

  1. Troponin excretion in urine compared to creatinine

    Time frame: 1 year

    Comparing urine troponin levels to urine creatinine, albumin, β2-microglobulin

  2. Troponin excretion in urine compared to albumin

    Time frame: 1 year

    Comparing urine troponin levels to urine albumin

  3. Troponin excretion in urine compared to β2-microglobulin

    Time frame: 1 year

    Comparing urine troponin levels to urine β2-microglobulin

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 26, 2019
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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