Sepsis Clinical Trial
— COMTESSOfficial title:
Coronary Microcirculation and Troponin Elevation in Septic Shock
NCT number | NCT06294730 |
Other study ID # | 2018/1891-31 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 13, 2019 |
Est. completion date | December 2024 |
Plasma cardiac troponin (cTn) elevation is an indicator of increased mortality in patients with sepsis yet the underlying cause of troponin elevation in sepsis is not known. The COMTESS study investigates whether elevated high-sensitive cardiac Troponin T (hs-cTnT) levels in hemodynamically unstable patients with sepsis can be explained by an underlying coronary artery disease or a process within the coronary microcirculation. Fifty patients with sepsis and with hs-cTnT elevation (>15 ng/L) will undergo coronary angiography, including an assessment of coronary flow using a method called thermo-dilution to record the index of microcirculatory resistance (IMR) in the left anterior descending artery (LAD). The relationship between IMR and hs-cTnT will subsequently be analysed. It is important to identify the underlying causes of elevated cTn during sepsis to target further research with an aim to improve the survival in patients suffering from this condition.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility | Inclusion Criteria: - Patients fulfilling the Sepsis-3 definition of and diagnostic criteria for sepsis or septic shock - Age 40 - 85 years - Life expectancy > 1 year - hs-cTnT values >15 ng/L Exclusion Criteria: - pregnancy - previous medical history of coronary artery by-pass grafting - heart transplant - previously verified ejection fraction (EF) =39% prior to hospital admission - Hypertrophic cardiomyopathy (Septum > 15 mm) - severe aortic stenosis - amyloidosis or sarcoidosis with myocardial engagement - estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 prior to hospital admission - asthma - infectious endocarditis - a medical history of abdominal, thoracic, or orthopaedic surgery within the last three months prior to hospital admission. |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska Institutet, Danderyd University Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet |
Sweden,
Aarnoudse W, Fearon WF, Manoharan G, Geven M, van de Vosse F, Rutten M, De Bruyne B, Pijls NH. Epicardial stenosis severity does not affect minimal microcirculatory resistance. Circulation. 2004 Oct 12;110(15):2137-42. doi: 10.1161/01.CIR.0000143893.18451.0E. Epub 2004 Oct 4. — View Citation
Colicchia M, Perrella G, Gant P, Rayes J. Novel mechanisms of thrombo-inflammation during infection: spotlight on neutrophil extracellular trap-mediated platelet activation. Res Pract Thromb Haemost. 2023 Mar 11;7(2):100116. doi: 10.1016/j.rpth.2023.100116. eCollection 2023 Feb. — View Citation
Cox D. Sepsis - it is all about the platelets. Front Immunol. 2023 Jun 7;14:1210219. doi: 10.3389/fimmu.2023.1210219. eCollection 2023. — View Citation
De Backer D, Donadello K, Sakr Y, Ospina-Tascon G, Salgado D, Scolletta S, Vincent JL. Microcirculatory alterations in patients with severe sepsis: impact of time of assessment and relationship with outcome. Crit Care Med. 2013 Mar;41(3):791-9. doi: 10.1097/CCM.0b013e3182742e8b. — View Citation
De Bruyne B, Pijls NH, Smith L, Wievegg M, Heyndrickx GR. Coronary thermodilution to assess flow reserve: experimental validation. Circulation. 2001 Oct 23;104(17):2003-6. doi: 10.1161/hc4201.099223. — View Citation
Fearon WF, Aarnoudse W, Pijls NH, De Bruyne B, Balsam LB, Cooke DT, Robbins RC, Fitzgerald PJ, Yeung AC, Yock PG. Microvascular resistance is not influenced by epicardial coronary artery stenosis severity: experimental validation. Circulation. 2004 May 18;109(19):2269-72. doi: 10.1161/01.CIR.0000128669.99355.CB. Epub 2004 May 10. — View Citation
Fearon WF, Balsam LB, Farouque HM, Caffarelli AD, Robbins RC, Fitzgerald PJ, Yock PG, Yeung AC. Novel index for invasively assessing the coronary microcirculation. Circulation. 2003 Jul 1;107(25):3129-32. doi: 10.1161/01.CIR.0000080700.98607.D1. Epub 2003 Jun 23. Erratum In: Circulation. 2003 Dec 23;108(25):3165. — View Citation
Fearon WF, Nakamura M, Lee DP, Rezaee M, Vagelos RH, Hunt SA, Fitzgerald PJ, Yock PG, Yeung AC. Simultaneous assessment of fractional and coronary flow reserves in cardiac transplant recipients: Physiologic Investigation for Transplant Arteriopathy (PITA Study). Circulation. 2003 Sep 30;108(13):1605-10. doi: 10.1161/01.CIR.0000091116.84926.6F. Epub 2003 Sep 8. — View Citation
Fernandez-Sarmiento J, Molina CF, Salazar-Pelaez LM, Florez S, Alarcon-Forero LC, Sarta M, Hernandez-Sarmiento R, Villar JC. Biomarkers of Glycocalyx Injury and Endothelial Activation are Associated with Clinical Outcomes in Patients with Sepsis: A Systematic Review and Meta-Analysis. J Intensive Care Med. 2023 Jan;38(1):95-105. doi: 10.1177/08850666221109186. Epub 2022 Jun 19. — View Citation
Levy MM, Artigas A, Phillips GS, Rhodes A, Beale R, Osborn T, Vincent JL, Townsend S, Lemeshow S, Dellinger RP. Outcomes of the Surviving Sepsis Campaign in intensive care units in the USA and Europe: a prospective cohort study. Lancet Infect Dis. 2012 Dec;12(12):919-24. doi: 10.1016/S1473-3099(12)70239-6. Epub 2012 Oct 26. — View Citation
Lorstad S, Shekarestan S, Jernberg T, Tehrani S, Astrand P, Gille-Johnson P, Persson J. First Sampled High-Sensitive Cardiac Troponin T is Associated With One-Year Mortality in Sepsis Patients and 30- to 365-Day Mortality in Sepsis Survivors. Am J Med. 2023 Aug;136(8):814-823.e8. doi: 10.1016/j.amjmed.2023.04.029. Epub 2023 May 6. — View Citation
Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available. Erratum In: Eur Heart J. 2019 Oct 1;40(37):3096. — View Citation
Ong P, Camici PG, Beltrame JF, Crea F, Shimokawa H, Sechtem U, Kaski JC, Bairey Merz CN; Coronary Vasomotion Disorders International Study Group (COVADIS). International standardization of diagnostic criteria for microvascular angina. Int J Cardiol. 2018 Jan 1;250:16-20. doi: 10.1016/j.ijcard.2017.08.068. Epub 2017 Sep 8. — View Citation
Piotti A, Novelli D, Meessen JMTA, Ferlicca D, Coppolecchia S, Marino A, Salati G, Savioli M, Grasselli G, Bellani G, Pesenti A, Masson S, Caironi P, Gattinoni L, Gobbi M, Fracasso C, Latini R; ALBIOS Investigators. Endothelial damage in septic shock patients as evidenced by circulating syndecan-1, sphingosine-1-phosphate and soluble VE-cadherin: a substudy of ALBIOS. Crit Care. 2021 Mar 19;25(1):113. doi: 10.1186/s13054-021-03545-1. — View Citation
Sun T, Wang Y, Wu X, Cai Y, Zhai T, Zhan Q. Prognostic Value of Syndecan-1 in the Prediction of Sepsis-Related Complications and Mortality: A Meta-Analysis. Front Public Health. 2022 Apr 11;10:870065. doi: 10.3389/fpubh.2022.870065. eCollection 2022. — View 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). J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264. doi: 10.1016/j.jacc.2018.08.1038. Epub 2018 Aug 25. No abstract available. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relationship between hs-cTnT and IMR | Spline regression between the highest hs-cTnT at 0-72 hrs from vasopressor initiation and IMR at day 2-10 from sepsis onset | Day 2-10 from the onset of sepsis symptoms. | |
Secondary | Relationship between hs-cTnT and CFR | Spline regression between the highest log hs-cTnT at 0-72 hrs from vasopressor initiation and CFR at day 2-10 from sepsis onset | Day 2-10 from the onset of sepsis symptoms. | |
Secondary | Relationship between hs-cTnT and BRI | Spline regression between the highest hs-cTnT at 0-72 hrs from vasopressor initiation and and BRI at day 2-10 from sepsis onset | Day 2-10 from the onset of sepsis symptoms | |
Secondary | Relationship between hs-cTnT and number of diseased epicardial coronary vessels | ANOVA for the relationship between the highest hs-cTnT at 0-72 hrs from vasopressor initiation and number of diseased epicardial coronary vessels | Day 2-10 from the onset of sepsis symptoms | |
Secondary | Relationship between hs-cTnT and Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX)-score | Spline regression between the highest hs-cTnT at 0-72 hrs from vasopressor initiation and SYNTAX-score | Day 2-10 from the onset of sepsis symptoms | |
Secondary | Relationship between hs-cTnT and left ventricular end diastolic pressure (LVEDP) | Spline regression between the highest hs-cTnT at 0-72 hrs from vasopressor initiation and LVEDP (mmHg) | Day 2-10 from the onset of sepsis symptoms | |
Secondary | Relationship between hs-cTnT and Tricuspid annular plane systolic excursion (TAPSE) | Spline regression between the highest hs-cTnT at 0-72 hrs and Tricuspid annular plane systolic excursion TAPSE (mm) | Day 2-10 from the onset of sepsis symptoms | |
Secondary | Relationship between hs-cTnT and echocardiographic measurements of left ventricular global strain | Spline regression between the highest hs-cTnT at 0-72 hrs from vasopressor initiation and left ventricular global strain from speckle tracking (units) | Day 2-10 from the onset of sepsis symptoms | |
Secondary | Relationship between hs-cTnT and echocardiographic measurements of left diastolic dysfunction | ANOVA between the highest hs-cTnT at 0-72 hrs from vasopressor initiation and left ventricular diastolic function grouping (none; grade I, impaired relaxation; grade II, pseudonormalization; grade III, restrictive filling) | Day 2-10 from the onset of sepsis symptoms | |
Secondary | Relationship between measures of endothelial dysfunction and IMR | Spline regression between plasma levels of syndecan-1 and IMR (units) | Day 2-10 from the onset of sepsis symptoms | |
Secondary | Relationship between measures NETs and IMR | Spline regression between NETs in plasma and IMR | Day 2-10 from the onset of sepsis symptoms |
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