Clinical Trials Directory

Trials / Completed

CompletedNCT04211610

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

Status
Completed
Phase
Study type
Observational
Enrollment
131 (actual)
Sponsor
Soroka University Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTBlood 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.

Timeline

Start date
2020-01-01
Primary completion
2023-12-31
Completion
2023-12-31
First posted
2019-12-26
Last updated
2024-01-17

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT04211610. Inclusion in this directory is not an endorsement.