Cardiac Injury in COVID-19: a Pathology Study

NCT04367792 | Unknown

• 1 other identifier: 56/20
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Covid-19; Infectious disease; Health care; Heart disease; Viruses; Myocarditis; Pathology

Outcome Measures

Primary Outcomes (3)

• Cardiac pathological findings from series of 60 patients dying from COVID-19 disease

  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

  1 year

• viral load in cardiac tissues and the extent of damage

  Understand the relationship between viral load in cardiac tissues and the extent of damage seen on myocardial histological sections

  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

  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.

  1 year

Secondary Outcomes (1)

• Multi-organ involvement obtained from hystological analyses of paraffine blocks from different organs (ie kidney, spleen, bowel,....)

  1 year

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• COVID-19 negative patients who died

Sponsors & Collaborators

• A.O. Ospedale Papa Giovanni XXIII: lead
• CVPath Institute Inc. Renu Virmani, Aloke Finn: collaborator
• A.O. Ospedale Papa Giovanni XXIII, Anatomia Patologica, Dr Andrea Gianatti, co-PI: collaborator

Study Sites (1)

ASST Ospedale Papa Giovanni XXIII

Bergamo, 24127, Italy

Location

Related Publications (7)

• 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.

  PMID: 32211816 BACKGROUND

• 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.

  PMID: 32219356 BACKGROUND

• Madjid M, Safavi-Naeini P, Solomon SD, Vardeny O. Potential Effects of Coronaviruses on the Cardiovascular System: A Review. JAMA Cardiol. 2020 Jul 1;5(7):831-840. doi: 10.1001/jamacardio.2020.1286.

  PMID: 32219363 BACKGROUND

• Chen T, Wu D, Chen H, Yan W, Yang D, Chen G, Ma K, Xu D, Yu H, Wang H, Wang T, Guo W, Chen J, Ding C, Zhang X, Huang J, Han M, Li S, Luo X, Zhao J, Ning Q. Clinical characteristics of 113 deceased patients with coronavirus disease 2019: retrospective study. BMJ. 2020 Mar 26;368:m1091. doi: 10.1136/bmj.m1091.

  PMID: 32217556 BACKGROUND

• Alhogbani T. Acute myocarditis associated with novel Middle east respiratory syndrome coronavirus. Ann Saudi Med. 2016 Jan-Feb;36(1):78-80. doi: 10.5144/0256-4947.2016.78.

  PMID: 26922692 BACKGROUND

• Zhong J, Basu R, Guo D, Chow FL, Byrns S, Schuster M, Loibner H, Wang XH, Penninger JM, Kassiri Z, Oudit GY. Angiotensin-converting enzyme 2 suppresses pathological hypertrophy, myocardial fibrosis, and cardiac dysfunction. Circulation. 2010 Aug 17;122(7):717-28, 18 p following 728. doi: 10.1161/CIRCULATIONAHA.110.955369. Epub 2010 Aug 2.

  PMID: 20679547 BACKGROUND

• Guo L, Akahori H, Harari E, Smith SL, Polavarapu R, Karmali V, Otsuka F, Gannon RL, Braumann RE, Dickinson MH, Gupta A, Jenkins AL, Lipinski MJ, Kim J, Chhour P, de Vries PS, Jinnouchi H, Kutys R, Mori H, Kutyna MD, Torii S, Sakamoto A, Choi CU, Cheng Q, Grove ML, Sawan MA, Zhang Y, Cao Y, Kolodgie FD, Cormode DP, Arking DE, Boerwinkle E, Morrison AC, Erdmann J, Sotoodehnia N, Virmani R, Finn AV. CD163+ macrophages promote angiogenesis and vascular permeability accompanied by inflammation in atherosclerosis. J Clin Invest. 2018 Mar 1;128(3):1106-1124. doi: 10.1172/JCI93025. Epub 2018 Feb 19.

  PMID: 29457790 BACKGROUND

MeSH Terms

Conditions

COVID-19; Communicable Diseases; Heart Diseases; Virus Diseases; Myocarditis

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases; Cardiomyopathies

Study Officials

• CTC CLINICAL TRIAL CENTER

  Clinical Trials Center - Ospedale Papa Giovanni XXIII Bergamo

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Cardiologist

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 29, 2020
• Study Start: April 23, 2020
• Primary Completion: October 1, 2020
• Study Completion: March 1, 2021
• Last Updated: August 10, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)