The Role of Ischemia Modified Albumin in Patients With COVID-19

NCT05286268 | Unknown

• 1 other identifier: 24918
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to recognize the diagnostic and/or prognostic value of IMA, as It reflects the degree of ischemia regardless of the affected organ. Our sample, which will be taken from the Pulmonology/Covid-19 Department and the Outpatient Clinic of the Pulmonology Department of University Hospital of Larissa, will be divided into two groups. The first group will be the study group, which will include patients with confirmed COVID-19 infection, while the second group will be the control group, which will include healthy volunteers. From the study population will be collected demographics, medical history, medication, symptoms, vital points, arterial blood gases, viral load from RT-PCR for SARS-COV2 and findings from imaging and laboratory assessment. On a daily basis, during their treatment, their vital points, their laboratory tests and the presence of possible complications will be recorded. Expected results are: 1) Comparison of IMA levels between COVID-19 patients and healthy volunteers, 2) The IMA contribution, during their admission to the hospital, to the prediction of the risk of deterioration and severe respiratory failure, 3) The increase of the predictive accuracy of SuPAR as a risk stratification biomarker, after its combination with IMA, 4) The estimation of IMA on the 10th day of illness in patients with severe respiratory failure, 5) The possibility of predicting with greater accuracy the probability of admission to the ICU, by measuring the IMA on the 10th day of illness compared to the IMA of admission.

Conditions

COVID-19

Keywords

COVID-19; SARS-CoV-2; Ischemia Modified Albumin; IMA; Prognosis

Outcome Measures

Primary Outcomes (1)

• Hospitalization outcome

  Admission to ICU, death, discharge

  Up to 8 weeks

Study Arms (2)

Study group

Patients with confirmed COVID-19 disease

Diagnostic Test: Ischemia Modified Albumin

Control group

Healthy volunteers without any of the exclusion criteria

Diagnostic Test: Ischemia Modified Albumin

Interventions

Ischemia Modified Albumin DIAGNOSTIC_TEST

Blood sampling at admission for measurement of IMA and suPAR levels and at day 10 from symptom onset (peak of symptoms) for IMA level. Samples will be collected in blood collection tubes containing K2EDTA as anticoagulant and serum separation gel tubes for SuPAR and IMA assays respectively. The samples will be centrifuged (at 3000 x g for 10 minutes) within the first 3 hours of sampling. Then, both plasma and serum samples will be placed in Eppendorf tubes and stored at -80oC. IMA levels will be determined according to the principles of the ACB assay, using the commercially available "Ischemia Modified Albumin Assay Kit" method (Abbexa LTD, Cambridge, UK), on the Architect c8000 automatic analytical system (Abbott, USA). SuPAR levels will be determined by the suPARnostic TurbiLatex quantitative turbidimetric immunoassay (ViroGates A/S, Denmark), also on the Architect c8000 automatic analytical system.

Also known as: Soluble Urokinase Plasminogen Activator Receptor

Control group; Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive adult patients who are admitted to the Hospital due to Covid-19

You may qualify if:

• \> 18 years old
• Positive nasopharyngeal test for SARS-CoV-2 confirmed by RT-PCR

You may not qualify if:

• Age \< 18 years old
• SARS-CoV-2 infection not confirmed by RT PCR
• No consent for participation in the study
• Acute ischemic disease prior to SARS-CoV-2 (trauma, mesenteric ischemia, stroke, liver disease, venous thromboembolic disease, acute coronary syndrome in the last 3 months, etc.)
• Pregnancy
• Immunosuppression
• Albumin \< 2gr/dl or \> 5.5gr/dl

Sponsors & Collaborators

• Larissa University Hospital: lead

Study Sites (1)

Larissa University Hospital

Larissa, Thessaly, 41334, Greece

RECRUITING

Related Publications (39)

• Varga Z, Flammer AJ, Steiger P, Haberecker M, Andermatt R, Zinkernagel AS, Mehra MR, Schuepbach RA, Ruschitzka F, Moch H. Endothelial cell infection and endotheliitis in COVID-19. Lancet. 2020 May 2;395(10234):1417-1418. doi: 10.1016/S0140-6736(20)30937-5. Epub 2020 Apr 21. No abstract available.

  PMID: 32325026 BACKGROUND

• Steinberg BE, Goldenberg NM, Lee WL. Do viral infections mimic bacterial sepsis? The role of microvascular permeability: A review of mechanisms and methods. Antiviral Res. 2012 Jan;93(1):2-15. doi: 10.1016/j.antiviral.2011.10.019. Epub 2011 Nov 2.

  PMID: 22068147 BACKGROUND

• Goeijenbier M, van Wissen M, van de Weg C, Jong E, Gerdes VE, Meijers JC, Brandjes DP, van Gorp EC. Review: Viral infections and mechanisms of thrombosis and bleeding. J Med Virol. 2012 Oct;84(10):1680-96. doi: 10.1002/jmv.23354.

  PMID: 22930518 BACKGROUND

• Ackermann M, Verleden SE, Kuehnel M, Haverich A, Welte T, Laenger F, Vanstapel A, Werlein C, Stark H, Tzankov A, Li WW, Li VW, Mentzer SJ, Jonigk D. Pulmonary Vascular Endothelialitis, Thrombosis, and Angiogenesis in Covid-19. N Engl J Med. 2020 Jul 9;383(2):120-128. doi: 10.1056/NEJMoa2015432. Epub 2020 May 21.

  PMID: 32437596 BACKGROUND

• Menter T, Haslbauer JD, Nienhold R, Savic S, Hopfer H, Deigendesch N, Frank S, Turek D, Willi N, Pargger H, Bassetti S, Leuppi JD, Cathomas G, Tolnay M, Mertz KD, Tzankov A. Postmortem examination of COVID-19 patients reveals diffuse alveolar damage with severe capillary congestion and variegated findings in lungs and other organs suggesting vascular dysfunction. Histopathology. 2020 Aug;77(2):198-209. doi: 10.1111/his.14134. Epub 2020 Jul 5.

  PMID: 32364264 BACKGROUND

• Wichmann D, Sperhake JP, Lutgehetmann M, Steurer S, Edler C, Heinemann A, Heinrich F, Mushumba H, Kniep I, Schroder AS, Burdelski C, de Heer G, Nierhaus A, Frings D, Pfefferle S, Becker H, Bredereke-Wiedling H, de Weerth A, Paschen HR, Sheikhzadeh-Eggers S, Stang A, Schmiedel S, Bokemeyer C, Addo MM, Aepfelbacher M, Puschel K, Kluge S. Autopsy Findings and Venous Thromboembolism in Patients With COVID-19: A Prospective Cohort Study. Ann Intern Med. 2020 Aug 18;173(4):268-277. doi: 10.7326/M20-2003. Epub 2020 May 6.

  PMID: 32374815 BACKGROUND

• Klok FA, Kruip MJHA, van der Meer NJM, Arbous MS, Gommers DAMPJ, Kant KM, Kaptein FHJ, van Paassen J, Stals MAM, Huisman MV, Endeman H. Incidence of thrombotic complications in critically ill ICU patients with COVID-19. Thromb Res. 2020 Jul;191:145-147. doi: 10.1016/j.thromres.2020.04.013. Epub 2020 Apr 10.

  PMID: 32291094 BACKGROUND

• Cui S, Chen S, Li X, Liu S, Wang F. Prevalence of venous thromboembolism in patients with severe novel coronavirus pneumonia. J Thromb Haemost. 2020 Jun;18(6):1421-1424. doi: 10.1111/jth.14830. Epub 2020 May 6.

  PMID: 32271988 BACKGROUND

• Lodigiani C, Iapichino G, Carenzo L, Cecconi M, Ferrazzi P, Sebastian T, Kucher N, Studt JD, Sacco C, Bertuzzi A, Sandri MT, Barco S; Humanitas COVID-19 Task Force. Venous and arterial thromboembolic complications in COVID-19 patients admitted to an academic hospital in Milan, Italy. Thromb Res. 2020 Jul;191:9-14. doi: 10.1016/j.thromres.2020.04.024. Epub 2020 Apr 23.

  PMID: 32353746 BACKGROUND

• Artifoni M, Danic G, Gautier G, Gicquel P, Boutoille D, Raffi F, Neel A, Lecomte R. Systematic assessment of venous thromboembolism in COVID-19 patients receiving thromboprophylaxis: incidence and role of D-dimer as predictive factors. J Thromb Thrombolysis. 2020 Jul;50(1):211-216. doi: 10.1007/s11239-020-02146-z.

  PMID: 32451823 BACKGROUND

• Middeldorp S, Coppens M, van Haaps TF, Foppen M, Vlaar AP, Muller MCA, Bouman CCS, Beenen LFM, Kootte RS, Heijmans J, Smits LP, Bonta PI, van Es N. Incidence of venous thromboembolism in hospitalized patients with COVID-19. J Thromb Haemost. 2020 Aug;18(8):1995-2002. doi: 10.1111/jth.14888. Epub 2020 Jul 27.

  PMID: 32369666 BACKGROUND

• Vacirca A, Faggioli G, Pini R, Teutonico P, Pilato A, Gargiulo M. Unheralded Lower limb threatening ischemia in a COVID-19 patient. Int J Infect Dis. 2020 Jul;96:590-592. doi: 10.1016/j.ijid.2020.05.060. Epub 2020 May 22.

  PMID: 32447121 BACKGROUND

• Kaur P, Qaqa F, Ramahi A, Shamoon Y, Singhal M, Shamoon F, Maroules M, Singh B. Acute upper limb ischemia in a patient with COVID-19. Hematol Oncol Stem Cell Ther. 2021 Dec;14(4):348-350. doi: 10.1016/j.hemonc.2020.05.001. Epub 2020 May 13.

  PMID: 32405288 BACKGROUND

• Bansal M. Cardiovascular disease and COVID-19. Diabetes Metab Syndr. 2020 May-Jun;14(3):247-250. doi: 10.1016/j.dsx.2020.03.013. Epub 2020 Mar 25.

  PMID: 32247212 BACKGROUND

• Shi S, Qin M, Shen B, Cai Y, Liu T, Yang F, Gong W, Liu X, Liang J, Zhao Q, Huang H, Yang B, Huang C. Association of Cardiac Injury With Mortality in Hospitalized Patients With COVID-19 in Wuhan, China. JAMA Cardiol. 2020 Jul 1;5(7):802-810. doi: 10.1001/jamacardio.2020.0950.

  PMID: 32211816 BACKGROUND

• Lippi G, Lavie CJ, Sanchis-Gomar F. Cardiac troponin I in patients with coronavirus disease 2019 (COVID-19): Evidence from a meta-analysis. Prog Cardiovasc Dis. 2020 May-Jun;63(3):390-391. doi: 10.1016/j.pcad.2020.03.001. Epub 2020 Mar 10. No abstract available.

  PMID: 32169400 BACKGROUND

• Clerkin KJ, Fried JA, Raikhelkar J, Sayer G, Griffin JM, Masoumi A, Jain SS, Burkhoff D, Kumaraiah D, Rabbani L, Schwartz A, Uriel N. COVID-19 and Cardiovascular Disease. Circulation. 2020 May 19;141(20):1648-1655. doi: 10.1161/CIRCULATIONAHA.120.046941. Epub 2020 Mar 21.

  PMID: 32200663 BACKGROUND

• Bhatraju PK, Ghassemieh BJ, Nichols M, Kim R, Jerome KR, Nalla AK, Greninger AL, Pipavath S, Wurfel MM, Evans L, Kritek PA, West TE, Luks A, Gerbino A, Dale CR, Goldman JD, O'Mahony S, Mikacenic C. Covid-19 in Critically Ill Patients in the Seattle Region - Case Series. N Engl J Med. 2020 May 21;382(21):2012-2022. doi: 10.1056/NEJMoa2004500. Epub 2020 Mar 30.

  PMID: 32227758 BACKGROUND

• Guo T, Fan Y, Chen M, Wu X, Zhang L, He T, Wang H, Wan J, Wang X, Lu Z. Cardiovascular Implications of Fatal Outcomes of Patients With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):811-818. doi: 10.1001/jamacardio.2020.1017.

  PMID: 32219356 BACKGROUND

• Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

  PMID: 31986264 BACKGROUND

• Clinical characteristics of 113 deceased patients with coronavirus disease 2019: retrospective study. BMJ. 2020 Mar 31;368:m1295. doi: 10.1136/bmj.m1295. No abstract available.

  PMID: 32234718 BACKGROUND

• Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

  PMID: 32171076 BACKGROUND

• Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

  PMID: 32031570 BACKGROUND

• Avula A, Nalleballe K, Narula N, Sapozhnikov S, Dandu V, Toom S, Glaser A, Elsayegh D. COVID-19 presenting as stroke. Brain Behav Immun. 2020 Jul;87:115-119. doi: 10.1016/j.bbi.2020.04.077. Epub 2020 Apr 28.

  PMID: 32360439 BACKGROUND

• Oxley TJ, Mocco J, Majidi S, Kellner CP, Shoirah H, Singh IP, De Leacy RA, Shigematsu T, Ladner TR, Yaeger KA, Skliut M, Weinberger J, Dangayach NS, Bederson JB, Tuhrim S, Fifi JT. Large-Vessel Stroke as a Presenting Feature of Covid-19 in the Young. N Engl J Med. 2020 May 14;382(20):e60. doi: 10.1056/NEJMc2009787. Epub 2020 Apr 28. No abstract available.

  PMID: 32343504 BACKGROUND

• Mao L, Jin H, Wang M, Hu Y, Chen S, He Q, Chang J, Hong C, Zhou Y, Wang D, Miao X, Li Y, Hu B. Neurologic Manifestations of Hospitalized Patients With Coronavirus Disease 2019 in Wuhan, China. JAMA Neurol. 2020 Jun 1;77(6):683-690. doi: 10.1001/jamaneurol.2020.1127.

  PMID: 32275288 BACKGROUND

• Varatharaj A, Thomas N, Ellul MA, Davies NWS, Pollak TA, Tenorio EL, Sultan M, Easton A, Breen G, Zandi M, Coles JP, Manji H, Al-Shahi Salman R, Menon DK, Nicholson TR, Benjamin LA, Carson A, Smith C, Turner MR, Solomon T, Kneen R, Pett SL, Galea I, Thomas RH, Michael BD; CoroNerve Study Group. Neurological and neuropsychiatric complications of COVID-19 in 153 patients: a UK-wide surveillance study. Lancet Psychiatry. 2020 Oct;7(10):875-882. doi: 10.1016/S2215-0366(20)30287-X. Epub 2020 Jun 25.

  PMID: 32593341 BACKGROUND

• Romero-Sanchez CM, Diaz-Maroto I, Fernandez-Diaz E, Sanchez-Larsen A, Layos-Romero A, Garcia-Garcia J, Gonzalez E, Redondo-Penas I, Perona-Moratalla AB, Del Valle-Perez JA, Gracia-Gil J, Rojas-Bartolome L, Feria-Vilar I, Monteagudo M, Palao M, Palazon-Garcia E, Alcahut-Rodriguez C, Sopelana-Garay D, Moreno Y, Ahmad J, Segura T. Neurologic manifestations in hospitalized patients with COVID-19: The ALBACOVID registry. Neurology. 2020 Aug 25;95(8):e1060-e1070. doi: 10.1212/WNL.0000000000009937. Epub 2020 Jun 1.

  PMID: 32482845 BACKGROUND

• Helms J, Tacquard C, Severac F, Leonard-Lorant I, Ohana M, Delabranche X, Merdji H, Clere-Jehl R, Schenck M, Fagot Gandet F, Fafi-Kremer S, Castelain V, Schneider F, Grunebaum L, Angles-Cano E, Sattler L, Mertes PM, Meziani F; CRICS TRIGGERSEP Group (Clinical Research in Intensive Care and Sepsis Trial Group for Global Evaluation and Research in Sepsis). High risk of thrombosis in patients with severe SARS-CoV-2 infection: a multicenter prospective cohort study. Intensive Care Med. 2020 Jun;46(6):1089-1098. doi: 10.1007/s00134-020-06062-x. Epub 2020 May 4.

  PMID: 32367170 BACKGROUND

• Bar-Or D, Lau E, Winkler JV. A novel assay for cobalt-albumin binding and its potential as a marker for myocardial ischemia-a preliminary report. J Emerg Med. 2000 Nov;19(4):311-5. doi: 10.1016/s0736-4679(00)00255-9.

  PMID: 11074321 BACKGROUND

• Pantazopoulos I, Papadimitriou L, Dontas I, Demestiha T, Iakovidou N, Xanthos T. Ischaemia modified albumin in the diagnosis of acute coronary syndromes. Resuscitation. 2009 Mar;80(3):306-10. doi: 10.1016/j.resuscitation.2008.10.035. Epub 2008 Dec 25.

  PMID: 19111377 BACKGROUND

• Kaya Z, Kayrak M, Gul EE, Altunbas G, Toker A, Kiyici A, Gunduz M, Alibasic H, Akilli H, Aribas A. The role of ischemia modified albumin in acute pulmonary embolism. Heart Views. 2014 Oct-Dec;15(4):106-10. doi: 10.4103/1995-705X.151083.

  PMID: 25774252 BACKGROUND

• Park J, Ahn S, Lee S, Song J, Moon S, Kim J, Cho H. Association of ischemia modified albumin with mortality in qSOFA positive sepsis patients by sepsis-3 in the emergency department. Am J Emerg Med. 2021 Jun;44:72-77. doi: 10.1016/j.ajem.2021.01.059. Epub 2021 Jan 29.

  PMID: 33582611 BACKGROUND

• Choo SH, Lim YS, Cho JS, Jang JH, Choi JY, Choi WS, Yang HJ. Usefulness of ischemia-modified albumin in the diagnosis of sepsis/septic shock in the emergency department. Clin Exp Emerg Med. 2020 Sep;7(3):161-169. doi: 10.15441/ceem.19.075. Epub 2020 Sep 30.

  PMID: 33028058 BACKGROUND

• Menon B, Ramalingam K, Krishna V. Study of Ischemia Modified Albumin as a Biomarker in Acute Ischaemic Stroke. Ann Neurosci. 2018 Dec;25(4):187-190. doi: 10.1159/000488188. Epub 2018 Jun 28.

  PMID: 31000956 BACKGROUND

• Balamir I, Ates I, Topcuoglu C, Turhan T. Association of Endocan, Ischemia-Modified Albumin, and hsCRP Levels With Endothelial Dysfunction in Type 2 Diabetes Mellitus. Angiology. 2018 Aug;69(7):609-616. doi: 10.1177/0003319717740781. Epub 2017 Nov 26.

  PMID: 29172652 BACKGROUND

• Balta S. Endothelial Dysfunction and Inflammatory Markers of Vascular Disease. Curr Vasc Pharmacol. 2021;19(3):243-249. doi: 10.2174/1570161118666200421142542.

  PMID: 32316894 BACKGROUND

• Chalkias A, Mouzarou A, Samara E, Xanthos T, Ischaki E, Pantazopoulos I. Soluble Urokinase Plasminogen Activator Receptor: A Biomarker for Predicting Complications and Critical Care Admission of COVID-19 Patients. Mol Diagn Ther. 2020 Oct;24(5):517-521. doi: 10.1007/s40291-020-00481-8.

  PMID: 32613288 BACKGROUND

• Rovina N, Akinosoglou K, Eugen-Olsen J, Hayek S, Reiser J, Giamarellos-Bourboulis EJ. Soluble urokinase plasminogen activator receptor (suPAR) as an early predictor of severe respiratory failure in patients with COVID-19 pneumonia. Crit Care. 2020 Apr 30;24(1):187. doi: 10.1186/s13054-020-02897-4. No abstract available.

  PMID: 32354367 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Athanasios D. Pagonis, Resident

  University Hospital of Larissa, Pulmonology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Athanasios D. Pagonis, Resident

CONTACT

(+30) 6982925353; thanos.pgns@gmail.com

Ioannis N. Pantazopoulos, Professor

CONTACT

(+30) 6945661525; pantazopoulosioannis@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonology resident

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 18, 2022
• Study Start: April 6, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Locations

GR (1)