Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04433026
Recruitment Status : Not yet recruiting
First Posted : June 16, 2020
Last Update Posted : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
Areej Osama Ali Mohammed Saleh, Assiut University

Brief 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

Condition or disease Intervention/treatment
COVID-19 Diagnostic Test: N terminal pro B type natriuretic peptide (NTproBNP), D-Dimer, and serum Tropinin - I

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)

Layout table for study information
Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: B-natriuretic Peptide (BNP), Serum Troponin-I, and D-dimer as Risk Factors for In-hospital Death in Patients With COVID-19
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : September 1, 2021

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


Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The study initially enrolled 90 patients with COVID-19
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04433026


Contacts
Layout table for location contacts
Contact: Areej Saleh +201007728031 areej.20123824@med.aun.edu

Sponsors and Collaborators
Assiut University
Publications:

Layout table for additonal information
Responsible Party: Areej Osama Ali Mohammed Saleh, Resident physician, Assiut University
ClinicalTrials.gov Identifier: NCT04433026    
Other Study ID Numbers: Cardiac markers in COVID-19
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs