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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Healthy subjects without any evidence of cardiac o | Inclusion criteria:
Blood and urine samples will be collected for troponin and other measures. |
| |
| Group 2 - Subjects with acute myocardial infarction and norm | Inclusion criteria:
Blood and urine samples will be collected for troponin and other measures. |
| |
| Group 3 - Subjects with acute myocardial infarction and decr | Inclusion criteria - Group 3a:
Blood and urine samples will be collected for troponin and other measures. |
| |
| Group 4 - Subjects with decreased GFR but without any eviden | Inclusion criteria - Group 4a:
Blood and urine samples will be collected for troponin and other measures. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood and urine sampling | Diagnostic Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Troponin excretion in urine compared to creatinine | Comparing urine troponin levels to urine creatinine, albumin, β2-microglobulin | 1 year |
| Troponin excretion in urine compared to albumin | Comparing urine troponin levels to urine albumin |
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Inclusion Criteria:
Exclusion Criteria:
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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 study population will be enrolled according to the above inclusion and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Yosef Haviv, MD | Soroka UMC, Nephrology Department, Director | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka Medical Center | Beersheba | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25948542 | Background | 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. | |
| 12505215 |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood and urine samples will be collected from each patient
|
| Group 5 - Subjects with chronic myocardial injury and normal | Inclusion criteria:
Blood and urine samples will be collected for troponin and other measures. |
|
| 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. |
|
| 1 year |
| Troponin excretion in urine compared to β2-microglobulin | Comparing urine troponin levels to urine β2-microglobulin | 1 year |
| 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. |
| 16531987 | 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. |
| 12816921 | 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. |
| 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 |
| 28193484 | 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. |
| 30154043 | 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. |
| 24148285 | 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |