BNP, Serum Troponin and D-dimer as Risk Factors in Patients With COVID-19

COVID-19 Clinical Trial

Official title:

B-natriuretic Peptide (BNP), Serum Troponin-I, and D-dimer as Risk Factors for In-hospital Death in Patients With COVID-19

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04433026
• Other study ID #: Cardiac markers in COVID-19
• Status: Not yet recruiting
• Start date: August 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: June 2020
• Source: Assiut University
• Contact: Areej Saleh
• Phone: +201007728031
• Email: areej.20123824[@]med.aun.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate the role of N terminal pro B type natriuretic peptide (NTproBNP), D-Dimer, and Troponin - I as risk factors in COVID-19 patients and to correlate these markers with in-hospital death in patients with COVID-19

Description:

Coronavirus disease-2019 (COVID-19), a contagious novel coronavirus now called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; formerly called 2019-nCoV).

Cardiac injury is a common condition among the hospitalized patients with COVID-19. It t was recently reported that 19.7% patients with COVID-19 had cardiac injury with more adverse clinical outcomes compared to those without cardiac injury (Shi S, et al, 2020) Fulminant myocarditis due to direct viral infection can certainly occur, but in patients with increased oxygen demands due to tachycardia and fever and reduced oxygen delivery due to hypotension and hypoxemia, COVID 19 disease can cause myocardial injury indirectly. Cytokines released during the acute infection can elicit activation of cells within pre-existing atherosclerotic lesions, augmenting thrombotic risk and risk of ischemic syndromes. Moreover, microvascular activation by cytokines can cause not only myocardial injury but can also harm other organ systems commonly involved in COVID-19 infections including the kidneys.(Peter,2020) Treatment in intensive care units (ICU) has become a major challenge; therefore, early recognition of severe forms is absolutely essential for timely triaging of patients. Several laboratory parameters may facilitate the assessment of disease severity. The recognized risk factors such as old age and underlying comorbidities-particularly cardiovascular diseases, diabetes, respiratory diseases, and other conditions (Zhou et al,2020) Several markers have been identified that modulate the course of COVID-19. The heart failure marker, N terminal pro B type natriuretic peptide (NT-proBNP), increased significantly during the course of hospitalization (Guo T, et al ,2020) The sensitivity of cardiac troponin testing that ensures it is one of the earliest and most precise indicators of end organ dysfunction. Cardiac troponin testing could prompt early initiation of measures to improve tissue oxygenation and perfusion.

COVID-19 infection is associated with intra-alveolar fibrin deposition, leading to lethal respiratory failure; reports suggesting that anticoagulation or fibrinolytic therapy can improve clinical outcomes (Wang J, et Al , 2020) ; case series implying that large percentages of severely affected COVID-19 patients suffer clinically significant thrombosis (Porfidia A , et al ,2020)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: September 1, 2021
• Est. primary completion date: July 1, 2021
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with COVID-19 (moderate and severe cases) Different age groups

Exclusion Criteria:

• Patients who had stroke and acute myocardial infarction, malignant tumor, and pregnancy.

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• N terminal pro B type natriuretic peptide (NTproBNP), D-Dimer, and serum Tropinin - I
Biomarkers detected in the serum of patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

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 Mar 27. doi: 10.1001/jamacardio.2020.1017. [Epub ahead of print] — View Citation

Libby P. The Heart in COVID-19: Primary Target or Secondary Bystander? JACC Basic Transl Sci. 2020 Apr 10;5(5):537-542. doi: 10.1016/j.jacbts.2020.04.001. eCollection 2020 May. — View Citation

Porfidia A, Pola R. Venous thromboembolism in COVID-19 patients. J Thromb Haemost. 2020 Jun;18(6):1516-1517. doi: 10.1111/jth.14842. — View Citation

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 Mar 25. doi: 10.1001/jamacardio.2020.0950. [Epub ahead of print] — View Citation

Wang J, Hajizadeh N, Moore EE, McIntyre RC, Moore PK, Veress LA, Yaffe MB, Moore HB, Barrett CD. Tissue plasminogen activator (tPA) treatment for COVID-19 associated acute respiratory distress syndrome (ARDS): A case series. J Thromb Haemost. 2020 Jul;18(7):1752-1755. doi: 10.1111/jth.14828. Epub 2020 May 11. — View Citation

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. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of N-terminal pro-B type natriuretic peptide, troponin-I and D-dimer in COVID-19 patients	Measurement of the level of these markers in COVID-19 patients and collerate these measurements with early signs of cardiac injury in COVID-19 patients	Baseline
Primary	Cardiac complications in COVID-19 patients associated with more adverse effects	Measurement of the level of N-terminal pro-B type natriuretic peptide, Troponin-I and D-dimer may help in detection of early signs of cardiac injury which in turn may help to minimize the risk of in-hospital deaths in COVID-19 patients	Baseline