Clinical trial NCT04211610: Troponin Excretion in Urine in Patients With and Without Chronic Kidney Disease
Official title: Troponin Excretion in Urine in Patients With and Without Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Acute Myocardial Infarction
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Troponin T in blood vs. urine
timeFrame: 1 year
measure: Troponin I in blood vs. urine
timeFrame: 1 year
Secondary outcomes:
measure: Troponin excretion in urine compared to creatinine
timeFrame: 1 year
measure: Troponin excretion in urine compared to albumin
timeFrame: 1 year
measure: Troponin excretion in urine compared to β2-microglobulin
timeFrame: 1 year
Other outcomes:
Locations:
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
Study officials:
affiliation: Soroka UMC, Nephrology Department, Director
name: Yosef Haviv, MD
role: STUDY_CHAIR
References:
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citation: Petra, P., Tomo, S., Ingrid, P., Jurica, V., Andrea, R., & Sonja, P. Urine Concentrations of High-Sensitivity Cardiac Troponin I in Healthy Adults - Preliminary Reference Intervals. Acta Med Croatica , 461-465, 2018
citation: Petra, P., Tomo, S., Ingrid, P., Ana, S., Matija, B., & Sonja, P. Urine High-Sensitive Troponin I Measuring in Patients with Hypertension. Signa Vitae , 13(SUPPL 3): 62-64, 2017
citation: Friden V, Starnberg K, Muslimovic A, Ricksten SE, Bjurman C, Forsgard N, Wickman A, Hammarsten O. Clearance of cardiac troponin T with and without kidney function. Clin Biochem. 2017 Jun;50(9):468-474. doi: 10.1016/j.clinbiochem.2017.02.007. Epub 2017 Feb 11.
citation: Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Glob Heart. 2018 Dec;13(4):305-338. doi: 10.1016/j.gheart.2018.08.004. Epub 2018 Aug 25. No abstract available.
citation: Dubin RF, Li Y, He J, Jaar BG, Kallem R, Lash JP, Makos G, Rosas SE, Soliman EZ, Townsend RR, Yang W, Go AS, Keane M, Defilippi C, Mishra R, Wolf M, Shlipak MG; CRIC Study Investigators. Predictors of high sensitivity cardiac troponin T in chronic kidney disease patients: a cross-sectional study in the chronic renal insufficiency cohort (CRIC). BMC Nephrol. 2013 Oct 22;14:229. doi: 10.1186/1471-2369-14-229.