Troponin Excretion in Urine in Patients With and Without Chronic Kidney Disease
NCT ID: NCT04211610
Last Updated: 2024-01-17
Study Results
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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COMPLETED
131 participants
OBSERVATIONAL
2020-01-01
2023-12-31
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
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
* 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
* 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
* 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
* 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
* 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
* 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.
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18
Exclusion Criteria
2. Patients after kidney transplantation.
3. Patients after heart transplantation.
4. Anuric patients.
18 Years
ALL
Yes
Sponsors
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Soroka University Medical Center
OTHER
Responsible Party
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Yasmeen Abu Fraiha
Internal Medicine Resident, Internal Medicine Department B
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
Countries
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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.
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.
Kanderian AS, Francis GS. Cardiac troponins and chronic kidney disease. Kidney Int. 2006 Apr;69(7):1112-4. doi: 10.1038/sj.ki.5000174.
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.
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
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
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.
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.
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.
Other Identifiers
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0234-19-SOR
Identifier Type: -
Identifier Source: org_study_id
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