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

Soroka University Medical Center

Status: Completed

Conditions: Chronic Kidney Diseases; Acute Myocardial Infarction

Treatments: Diagnostic Test: Blood and urine sampling

Study type: Observational

Funder types: Other

Identifiers

NCT04211610

0234-19-SOR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

131 participants in 6 patient groups

Group 1 - Healthy subjects without any evidence of cardiac o

Description:

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.

Treatment:

Diagnostic Test: Blood and urine sampling

Group 2 - Subjects with acute myocardial infarction and norm

Description:

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.

Treatment:

Diagnostic Test: Blood and urine sampling

Group 3 - Subjects with acute myocardial infarction and decr

Description:

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.

Treatment:

Diagnostic Test: Blood and urine sampling

Group 4 - Subjects with decreased GFR but without any eviden

Description:

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.

Treatment:

Diagnostic Test: Blood and urine sampling

Group 5 - Subjects with chronic myocardial injury and normal

Description:

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.

Treatment:

Diagnostic Test: Blood and urine sampling

Group 6 - patients on RRT

Description:

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.

Treatment:

Diagnostic Test: Blood and urine sampling