Cardiac Injury in COVID-19: a Pathology Study
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|ClinicalTrials.gov Identifier: NCT04367792|
Recruitment Status : Active, not recruiting
First Posted : April 29, 2020
Last Update Posted : August 10, 2020
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||Pathology and Pathogenesis of Cardiac Injury in COVID-19 Infections in Humans|
|Actual Study Start Date :||April 23, 2020|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||March 2021|
Patients died with Covid-19 disease
Sample of patients died with Covid-19 disease and pulmonary disease
Patients died with Covid-19 and cardiovascular disease
Sample of patients died with Covid-19 disease and pulmonary disease with clear cardiovascular involvement
Patient died with myocarditis
Sample of patient died with different types of myocarditis without Covid-19 disease. These samples are used as control and are part of database of previously collected samples of CVPath Institute Inc.
- Cardiac pathological findings from series of 60 patients dying from COVID-19 disease [ Time Frame: 1 year ]Describe the cardiac pathological findings from series of 60 patients dying from COVID-19 using cardiac samples sent to CVPath Institution from Papa Giovanni XXIII Hospital, Bergamo to study the correlations between clinical risk factors and myocardial findings and difference from other viral myocarditis
- viral load in cardiac tissues and the extent of damage [ Time Frame: 1 year ]Understand the relationship between viral load in cardiac tissues and the extent of damage seen on myocardial histological sections
- Co-localize the SARS-CoV-2 using RNAscope in situ hybridization, with its entry receptor ACE2 and serine protease TMPRSS2 in different cell types found in the heart [ Time Frame: 1 year ]Co-localize the SARS-CoV-2 using RNAscope in situ hybridization, with its entry receptor ACE2 and serine protease TMPRSS2 in different cell types found in the heart, such as endothelial, smooth muscle, myocardial, fibroblastic and inflammatory cells to better understand the pathogenesis of the disease.
- Multi-organ involvement obtained from hystological analyses of paraffine blocks from different organs (ie kidney, spleen, bowel,....) [ Time Frame: 1 year ]Multi-organ involvement associated with cardiac injury (microvascular and cardiomyocyte). If specific pathology is observed, additional sections from different organs (ie kidney, spleen, bowel) will be requested and submitted in paraffin blocks to determine the etiology of the findings. Histologic examination is performed to rule out any infiltrative or inflammatory process or any myofiber disarray of the myocardium, intramyocardial small vessel disease, including microvascular thrombosis of interstitial or focal fibrosis.
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): NCT04367792
|ASST Ospedale Papa Giovanni XXIII|
|Bergamo, Italy, 24127|
|Study Chair:||CTC CLINICAL TRIAL CENTER||Clinical Trials Center - Ospedale Papa Giovanni XXIII Bergamo|