Cardiac COVID-19 Health Care Workers

COVID-19 Clinical Trial

— CCC  

Official title:

Cardiac Involvement in Coronavirus (SARS-Cov-2) Infected Health Care Workers: The CCC Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04413071
• Other study ID #: CCC_2020
• Status: Completed
• Start date: May 25, 2020
• Est. completion date: June 12, 2020

Study information

• Verified date: June 2020
• Source: AORTICA Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study will analyze the prevalence of cardiac involvement of health care workers from the University Hospital of Salamanca (HUSA) who have overcome SARS-CoV-2 infection. Participants will undergo a clinical evaluation, electrocardiogram (EKG), cardiac magnetic resonance (CMR) and blood analysis including NT-proBNP, troponin, cellular and humoral immunity and genetics.

Description:

Most people infected with SARS-CoV-2 experience mild, self-limiting symptoms that have been managed in an outpatient setting and therefore have not undergone routine cardiac evaluation with EKG or cardiac imaging test. Similarly, although the emphasis has been placed on evaluating patients with severe respiratory symptoms, most of these patients have also not undergone cardiac imaging tests and; therefore, in both scenarios, possible myocarditis has not routinely evaluated.

The present study is designed to characterize cardiac involvement in individuals who have overcome the SARS-CoV-2 infection.

For that aim, the study is designed as an observational cross-sectional study. The target population are HUSA healthcare workers who have overcome SARS-CoV-2 infection, either symptomatic or asymptomatic, either having required hospital admission or not. Participants will undergo a clinical evaluation, electrocardiogram (EKG), cardiac magnetic resonance (CMR) and blood analysis including NT-proBNP, troponin, cellular and humoral immunity and genetics.

Main objectives of the study are to address the prevalence of myocardial damage suggestive of myocarditis and to address the prevalence of pericarditis in HUSA health care workers; both related to the systemic immune response to SARS-CoV-2 infection. As secondary objectives the study will further address other cardiac affections including: rhythm or conduction disorders, ischemic heart disease, dilatation of the right chambers, valve disease and will analyze the relationship between humoral and cellular immunity and the presence of cardiac involvement, and the genetic susceptibility in the development of cardiac involvement after SARS-CoV-2 infection.

The study will recruit 141 participants: 47 symptomatic hospitalized health care workers, 47 asymptomatic non-hospitalized health care workers, 47 asymptomatic health care workers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: June 12, 2020
• Est. primary completion date: June 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 71 Years

Eligibility

Inclusion Criteria:

• Have overcome the SARS-CoV-2 infection meeting any of the following criteria (i) positive result on a reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of a specimen collected on a nasopharyngeal swab followed by a second negative RT-PCR and at least 14 days from this negative RT-PCR; (ii) presence of IgM antibodies and negative RT-PCR after the antibody assessment; (iii) presence of neutralizing IgG antibodies and absence of IgM.

• stable clinical situation, which allows performing a CMR.

• signature of informed consent.

Exclusion Criteria:

• Presence of IgM antibodies without negative subsequent RT-PCR.

• Contraindications to perform RMC: (i) gadolinium allergy, (ii) presence of metallic material in the body, such as plates, screws, incompatible pacemakers, etc. (iii) claustrophobia, (iv) severe kidney failure, (v) severe liver failure, (vi) sickle cell anemia

Related Conditions & MeSH terms

• Cardiac Anomaly
• Cardiac Magnetic Resonance
• Cardiovascular Abnormalities
• Coronavirus
• Coronavirus Infections
• COVID-19
• Heart Defects, Congenital
• Myocarditis
• SARS-CoV 2

Intervention

Other:
• Passed infection of SARS-CoV-2
This is an observational design. Participants have passed infection from SARS-CoV-2 and a cardiac assessment is performed.

Locations

Country	Name	City	State
Spain	University Hospital of Salamanca	Salamanca

Sponsors (3)

Lead Sponsor	Collaborator
AORTICA Group	Instituto de Investigación Biomédica de Salamanca, Salamanca University Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocarditis	Prevalence of myocardial damage suggestive of myocarditis assessed by cardiac magnetic resonance	up to 3 months
Primary	Pericarditis	Prevalence of pericarditis assessed by clinical criteria	up to 3 months
Secondary	Atrial fibrillation	Prevalence of atrial fibrillation on EKG	up to 3 months
Secondary	Ischemic heart disease	Prevalence of ischemic heart disease assessed by cardiac magnetic resonance	up to 3 months
Secondary	Dilatation of right heart chambers	Prevalence of dilatation of right heart chambers assessed by cardiac magnetic resonance	up to 3 months
Secondary	Valvular hear disease	Prevalence of valvular heart disease assessed by cardiac magnetic resonance	up to 3 months
Secondary	Rhythm disorders	Prevalence of prolonged QT interval on EKG	up to 3 months