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

NCT04211610 | Completed

• 1 other identifier: 0234-19-SOR
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

• Troponin T in blood vs. urine

  Quantitative measurements of hs-cTnT in blood and urine

  1 year

• Troponin I in blood vs. urine

  Quantitative measurements of hs-cTnI in blood and urine

  1 year

Secondary Outcomes (3)

• Troponin excretion in urine compared to creatinine

  1 year

• Troponin excretion in urine compared to albumin

  1 year

• Troponin excretion in urine compared to β2-microglobulin

  1 year

Study Arms (6)

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.

Diagnostic Test: Blood and urine sampling

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.

Diagnostic Test: Blood and urine sampling

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.

Diagnostic Test: Blood and urine sampling

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.

Diagnostic Test: Blood and urine sampling

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.

Diagnostic Test: Blood and urine sampling

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.

Diagnostic Test: Blood and urine sampling

Interventions

Blood and urine sampling 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 1 - Healthy subjects without any evidence of cardiac o; Group 2 - Subjects with acute myocardial infarction and norm; Group 3 - Subjects with acute myocardial infarction and decr; Group 4 - Subjects with decreased GFR but without any eviden; Group 5 - Subjects with chronic myocardial injury and normal; Group 6 - patients on RRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who are able to give informed consent.
• Age ≥ 18

You may not qualify if:

• Pregnant women
• Patients after kidney transplantation.
• Patients after heart transplantation.
• Anuric patients.

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (1)

Soroka Medical Center

Beersheba, Israel

Location

Related Publications (9)

• 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.

  PMID: 25948542 BACKGROUND

• 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.

  PMID: 12505215 BACKGROUND

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

  PMID: 16531987 BACKGROUND

• 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.

  PMID: 12816921 BACKGROUND

• 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

  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

  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.

  PMID: 28193484 BACKGROUND

• 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.

  PMID: 30154043 BACKGROUND

• 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.

  PMID: 24148285 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine samples will be collected from each patient

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Yosef Haviv, MD

  Soroka UMC, Nephrology Department, Director

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal Medicine Resident, Internal Medicine Department B

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: December 26, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)