- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04433026
BNP, Serum Troponin and D-dimer as Risk Factors in Patients With COVID-19
B-natriuretic Peptide (BNP), Serum Troponin-I, and D-dimer as Risk Factors for In-hospital Death in Patients With COVID-19
Study Overview
Status
Conditions
Detailed 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)
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of N-terminal pro-B type natriuretic peptide, troponin-I and D-dimer in COVID-19 patients
Time Frame: Baseline
|
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
|
Cardiac complications in COVID-19 patients associated with more adverse effects
Time Frame: Baseline
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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. Erratum In: JAMA Cardiol. 2020 Jul 1;5(7):848.
- 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.
- 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.
- Porfidia A, Pola R. Venous thromboembolism in COVID-19 patients. J Thromb Haemost. 2020 Jun;18(6):1516-1517. doi: 10.1111/jth.14842. No abstract available.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Physiological Effects of Drugs
- Natriuretic Agents
- Natriuretic Peptide, Brain
Other Study ID Numbers
- Cardiac markers in COVID-19
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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