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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
Sponsor:
Collaborators:
CVPath Institute Inc. Renu Virmani, Aloke Finn
A.O. Ospedale Papa Giovanni XXIII, Anatomia Patologica, Dr Andrea Gianatti, co-PI
Information provided by (Responsible Party):
GGuagliumi, A.O. Ospedale Papa Giovanni XXIII

Brief Summary:
The primary goal of the study is to conduct the first systematic cardiac autopsy study in 60 patients dying from COVID-19 to understand the pathology and pathogenesis of cardiac injury in patients with COVID-19, with/without cardiovascular comorbidities. Such data is essential for understanding rate of involvement, type of involvement and degree of injury in patients contracting the disease.

Condition or disease
COVID-19

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Systematic cardiac autopsy study of at least 60 patients dying from COVID-19 in Italy to understand the pathology and pathogenesis of cardiac injury in patients with COVID-19. Correlations with autopsy findings will be made with available anonymized clinical data including EKG, echocardiography and cardiac catheterization (where available). The cardiac pathologlical characteristics of COVID-19 will be compared to 60 viral myocarditis cases that have previously been collected in CVPath Registry.
Criteria

Inclusion Criteria:

  • Hospitalized patients at Papa Giovanni XXIII Hospital, Bergamo, forefront of the COVIT-19 pandemic in Italy
  • COVID-19 positive patients who died with/without a picture of cardiac injury

Exclusion Criteria:

  • COVID-19 negative patients who died

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): NCT04367792


Locations
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Italy
ASST Ospedale Papa Giovanni XXIII
Bergamo, Italy, 24127
Sponsors and Collaborators
A.O. Ospedale Papa Giovanni XXIII
CVPath Institute Inc. Renu Virmani, Aloke Finn
A.O. Ospedale Papa Giovanni XXIII, Anatomia Patologica, Dr Andrea Gianatti, co-PI
Investigators
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Study Chair: CTC CLINICAL TRIAL CENTER Clinical Trials Center - Ospedale Papa Giovanni XXIII Bergamo
Publications:

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Responsible Party: GGuagliumi, MD Cardiologist, A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov Identifier: NCT04367792    
Other Study ID Numbers: 56/20
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GGuagliumi, A.O. Ospedale Papa Giovanni XXIII:
Covid-19
Infectious disease
Health care
Heart disease
Viruses
Myocarditis
Pathology