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

NCT ID: NCT04211610

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

131 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-12-31

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.

Conditions

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Chronic Kidney Diseases Acute Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group 1 - Healthy subjects without any evidence of cardiac o

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.

Blood and urine sampling

Intervention Type DIAGNOSTIC_TEST

* 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.

Group 2 - Subjects with acute myocardial infarction and norm

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.

Blood and urine sampling

Intervention Type DIAGNOSTIC_TEST

* 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.

Group 3 - Subjects with acute myocardial infarction and decr

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.

Blood and urine sampling

Intervention Type DIAGNOSTIC_TEST

* 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.

Group 4 - Subjects with decreased GFR but without any eviden

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.

Blood and urine sampling

Intervention Type DIAGNOSTIC_TEST

* 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.

Group 5 - Subjects with chronic myocardial injury and normal

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.

Blood and urine sampling

Intervention Type DIAGNOSTIC_TEST

* 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.

Group 6 - patients on RRT

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.

Blood and urine sampling

Intervention Type DIAGNOSTIC_TEST

* 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.

Interventions

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Blood 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Soroka University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yasmeen Abu Fraiha

Internal Medicine Resident, Internal Medicine Department B

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yosef Haviv, MD

Role: STUDY_CHAIR

Soroka UMC, Nephrology Department, Director

Locations

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Soroka Medical Center

Beersheba, , Israel

Site Status

Countries

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Israel

References

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Twerenbold R, Wildi K, Jaeger C, Gimenez MR, Reiter M, Reichlin T, Walukiewicz A, Gugala M, Krivoshei L, Marti N, Moreno Weidmann Z, Hillinger P, Puelacher C, Rentsch K, Honegger U, Schumacher C, Zurbriggen F, Freese M, Stelzig C, Campodarve I, Bassetti S, Osswald S, Mueller C. Optimal Cutoff Levels of More Sensitive Cardiac Troponin Assays for the Early Diagnosis of Myocardial Infarction in Patients With Renal Dysfunction. Circulation. 2015 Jun 9;131(23):2041-50. doi: 10.1161/CIRCULATIONAHA.114.014245. Epub 2015 May 6.

Reference Type BACKGROUND
PMID: 25948542 (View on PubMed)

Freda BJ, Tang WH, Van Lente F, Peacock WF, Francis GS. Cardiac troponins in renal insufficiency: review and clinical implications. J Am Coll Cardiol. 2002 Dec 18;40(12):2065-71. doi: 10.1016/s0735-1097(02)02608-6.

Reference Type BACKGROUND
PMID: 12505215 (View on PubMed)

Kanderian AS, Francis GS. Cardiac troponins and chronic kidney disease. Kidney Int. 2006 Apr;69(7):1112-4. doi: 10.1038/sj.ki.5000174.

Reference Type BACKGROUND
PMID: 16531987 (View on PubMed)

Ziebig R, Lun A, Hocher B, Priem F, Altermann C, Asmus G, Kern H, Krause R, Lorenz B, Mobes R, Sinha P. Renal elimination of troponin T and troponin I. Clin Chem. 2003 Jul;49(7):1191-3. doi: 10.1373/49.7.1191. No abstract available.

Reference Type BACKGROUND
PMID: 12816921 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 28193484 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30154043 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24148285 (View on PubMed)

Other Identifiers

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0234-19-SOR

Identifier Type: -

Identifier Source: org_study_id

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