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

Completed

• Conditions: Chronic Kidney Diseases; Acute Myocardial Infarction
• Interventions: Diagnostic Test: Blood and urine sampling

• Registration Number: NCT04211610
• Lead Sponsor: Soroka University Medical Center

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.

Study Timeline

• Study First Submitted: 2019-12-23
• Study First Submitted QC: 2019-12-23
• Study First Posted: 2019-12-26
• Study Start: 2020-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-13
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 5 - Subjects with chronic myocardial injury and normal	Blood and urine sampling	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.
Group 6 - patients on RRT	Blood and urine sampling	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.
Group 1 - Healthy subjects without any evidence of cardiac o	Blood and urine sampling	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.
Group 4 - Subjects with decreased GFR but without any eviden	Blood and urine sampling	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.
Group 2 - Subjects with acute myocardial infarction and norm	Blood and urine sampling	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.
Group 3 - Subjects with acute myocardial infarction and decr	Blood and urine sampling	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.

Primary Outcome Measures

Name	Time	Method
Troponin I in blood vs. urine	1 year	Quantitative measurements of hs-cTnI in blood and urine
Troponin T in blood vs. urine	1 year	Quantitative measurements of hs-cTnT in blood and urine

Secondary Outcome Measures

Name	Time	Method
Troponin excretion in urine compared to albumin	1 year	Comparing urine troponin levels to urine albumin
Troponin excretion in urine compared to creatinine	1 year	Comparing urine troponin levels to urine creatinine, albumin, β2-microglobulin
Troponin excretion in urine compared to β2-microglobulin	1 year	Comparing urine troponin levels to urine β2-microglobulin

Trial Locations

Locations (1)

Soroka Medical Center; 🇮🇱 Be'er Sheva, Israel