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

January 13, 2024 updated by: Yasmeen Abu Fraiha, Soroka University Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

131

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Be'er Sheva, Israel
        • Soroka Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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 study population will be enrolled according to the above inclusion and exclusion criteria.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1 - Healthy subjects without any evidence of cardiac o

Inclusion criteria:

  1. Normal serum troponin (below the 99th percentile)
  2. GFR 60ml/min
  3. Proteinuria <1gr/gr creatinine

Blood and urine samples will be collected for troponin and other measures.
Diagnostic test: Blood and urine sampling
  • 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.
Group 2 - Subjects with acute myocardial infarction and norm

Inclusion criteria:

  1. At least one measurements of serum troponin above the 99th percentile, with either a rise or fall in cardiac troponin levels.
  2. GFR 60ml/min/1.73m2

Blood and urine samples will be collected for troponin and other measures.
Diagnostic test: Blood and urine sampling
  • 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.
Group 3 - Subjects with acute myocardial infarction and decr

Inclusion criteria - Group 3a:

  1. At least one measurements of serum troponin above the 99th percentile, with either a rise or fall in cardiac troponin levels.

  2. 30 GFR <60ml/min/1.73m2

    Inclusion criteria - Group 3b:

  3. At least one measurements of serum troponin above the 99th percentile, with either a rise or fall in cardiac troponin levels.
  4. GFR <30ml/min/1.73m2

Blood and urine samples will be collected for troponin and other measures.
Diagnostic test: Blood and urine sampling
  • 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.
Group 4 - Subjects with decreased GFR but without any eviden

Inclusion criteria - Group 4a:

  1. Normal serum troponin (below the 99th percentile)
  2. No known past medical history of any cardiac disease and/or procedure.

  3. 30 GFR <60ml/min/1.73m2

    Inclusion criteria - Group 4b:

  4. Normal serum troponin (below the 99th percentile)
  5. No known past medical history of any cardiac disease and/or procedure.
  6. GFR <30ml/min/1.73m2

Blood and urine samples will be collected for troponin and other measures.
Diagnostic test: Blood and urine sampling
  • 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.
Group 5 - Subjects with chronic myocardial injury and normal

Inclusion criteria:

  1. At least one measurements of serum troponin above the 99th percentile, with neither a rise nor fall in cardiac troponin levels.
  2. GFR 60ml/min/1.73m2

Blood and urine samples will be collected for troponin and other measures.
Diagnostic test: Blood and urine sampling
  • 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.
Group 6 - patients on RRT

Inclusion criteria:

a. Patients who are dependent on renal replacement therapy, including hemodialysis, peritoneal or hemodiafiltration.

Blood and urine samples will be collected for troponin and other measures.
Diagnostic test: Blood and urine sampling
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Troponin T in blood vs. urine
Time Frame: 1 year
Quantitative measurements of hs-cTnT in blood and urine
1 year
Troponin I in blood vs. urine
Time Frame: 1 year
Quantitative measurements of hs-cTnI in blood and urine
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Troponin excretion in urine compared to creatinine
Time Frame: 1 year
Comparing urine troponin levels to urine creatinine, albumin, β2-microglobulin
1 year
Troponin excretion in urine compared to albumin
Time Frame: 1 year
Comparing urine troponin levels to urine albumin
1 year
Troponin excretion in urine compared to β2-microglobulin
Time Frame: 1 year
Comparing urine troponin levels to urine β2-microglobulin
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Investigators

  • Study Chair: Yosef Haviv, MD, Soroka UMC, Nephrology Department, Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

December 23, 2019

First Submitted That Met QC Criteria

December 23, 2019

First Posted (Actual)

December 26, 2019

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 13, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0234-19-SOR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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