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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Kidney Diseases, Acute Myocardial Infarction

Intervention / Treatment
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* Diagnostic Test: Blood and urine sampling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1 - Healthy subjects without any evidence of cardiac o<br>Inclusion criteria: Normal serum troponin (below the 99th percentile) GFR 60ml/min Proteinuria <1gr/gr creatinine Blood and urine samples will be collected for troponin and other measures. | Diagnostic Test: Blood and urine sampling<br>* 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.<br>|
| Group 2 - Subjects with acute myocardial infarction and norm<br>Inclusion criteria: At least one measurements of serum troponin above the 99th percentile, with either a rise or fall in cardiac troponin levels. GFR 60ml/min/1.73m2 Blood and urine samples will be collected for troponin and other measures. | Diagnostic Test: Blood and urine sampling<br>* 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.<br>|
| Group 3 - Subjects with acute myocardial infarction and decr<br>Inclusion criteria - Group 3a: At least one measurements of serum troponin above the 99th percentile, with either a rise or fall in cardiac troponin levels. 30 GFR <60ml/min/1.73m2 Inclusion criteria - Group 3b: At least one measurements of serum troponin above the 99th percentile, with either a rise or fall in cardiac troponin levels. GFR <30ml/min/1.73m2 Blood and urine samples will be collected for troponin and other measures. | Diagnostic Test: Blood and urine sampling<br>* 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.<br>|
| Group 4 - Subjects with decreased GFR but without any eviden<br>Inclusion criteria - Group 4a: Normal serum troponin (below the 99th percentile) No known past medical history of any cardiac disease and/or procedure. 30 GFR <60ml/min/1.73m2 Inclusion criteria - Group 4b: Normal serum troponin (below the 99th percentile) No known past medical history of any cardiac disease and/or procedure. GFR <30ml/min/1.73m2 Blood and urine samples will be collected for troponin and other measures. | Diagnostic Test: Blood and urine sampling<br>* 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.<br>|
| Group 5 - Subjects with chronic myocardial injury and normal<br>Inclusion criteria: At least one measurements of serum troponin above the 99th percentile, with neither a rise nor fall in cardiac troponin levels. GFR 60ml/min/1.73m2 Blood and urine samples will be collected for troponin and other measures. | Diagnostic Test: Blood and urine sampling<br>* 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.<br>|
| Group 6 - patients on RRT<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Troponin T in blood vs. urine | Quantitative measurements of hs-cTnT in blood and urine | 1 year | 
| Troponin I in blood vs. urine | 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 | Comparing urine troponin levels to urine creatinine, albumin, β2-microglobulin | 1 year | 
| Troponin excretion in urine compared to albumin | Comparing urine troponin levels to urine albumin | 1 year | 
| Troponin excretion in urine compared to β2-microglobulin | Comparing urine troponin levels to urine β2-microglobulin | 1 year |