SARS-CoV 2CCCNCT04413071
Cardiac COVID-19 Health Care Workers
An observational study of SARS-CoV 2 and COVID-19, run by AORTICA Group at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 71 years
- Conditions the study is for
- SARS-CoV 2, COVID-19, Coronavirus
- What is being tested?
- Passed infection of SARS-CoV-2
- How many people
- 142 participants
- Where
- 1 siteSpain
- Study dates
- 25 May 2020to 12 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population are Salamanca´s healthcare workers who have overcome SARS-CoV-2 infection, either symptomatic or asymptomatic, either having required hospital admission or not.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiac Involvement in Coronavirus (SARS-Cov-2) Infected Health Care Workers: The CCC Study
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.
Read the detailed 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
- Conditions
- SARS-CoV 2, COVID-19, Coronavirus, Cardiac Magnetic Resonance, Myocarditis, Cardiac Anomaly
- Being tested
- Passed infection of SARS-CoV-2
- Medical subject headings
- COVID-19, Coronavirus Infections, Myocarditis, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passed infection of SARS-CoV-2Other
This is an observational design. Participants have passed infection from SARS-CoV-2 and a cardiac assessment is performed.
| Study group | Role | What they receive |
|---|---|---|
| Health care workers | Health care workers from the University Hospital of Salamanca who have passed SARS-CoV-2 infection. Receives: Other: Passed infection of SARS-CoV-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocarditis
Prevalence of myocardial damage suggestive of myocarditis assessed by cardiac magnetic resonance
Measured: up to 3 months
Pericarditis
Prevalence of pericarditis assessed by clinical criteria
Measured: up to 3 months
Secondary outcomes (5)
Atrial fibrillation
Prevalence of atrial fibrillation on EKG
Measured: up to 3 months
Ischemic heart disease
Prevalence of ischemic heart disease assessed by cardiac magnetic resonance
Measured: up to 3 months
Dilatation of right heart chambers
Prevalence of dilatation of right heart chambers assessed by cardiac magnetic resonance
Measured: up to 3 months
Valvular hear disease
Prevalence of valvular heart disease assessed by cardiac magnetic resonance
Measured: up to 3 months
Rhythm disorders
Prevalence of prolonged QT interval on EKG
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start25 May 2020
- Primary completion12 Jun 2020
- Study completion12 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- AORTICA Group
- Sponsor type
- University, hospital or other
- Collaborators
- Salamanca University Hospital, Instituto de Investigación Biomédica de Salamanca
- Responsible party
- Principal investigator, Pedro L Sanchez, Salamanca University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413071
- Sponsor's protocol ID
- CCC_2020
- Acronym
- CCC
- Status last verified
- Jun 2020
- First submitted
- 23 May 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Involvement in Coronavirus (SARS-Cov-2) Infected Health Care Workers: The CCC Study
- ClinicalTrials.gov ID
- NCT04413071
- Acronym / sponsor ID
- CCC / CCC_2020
- Conditions
- SARS-CoV 2, COVID-19, Coronavirus, Cardiac Magnetic Resonance, Myocarditis, Cardiac Anomaly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- AORTICA GroupUniversity, hospital or other
- Collaborators
- Salamanca University Hospital, Instituto de Investigación Biomédica de Salamanca
- Study start
- 25 May 2020 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health care workers | – | Other: Passed infection of SARS-CoV-2Health care workers from the University Hospital of Salamanca who have passed SARS-CoV-2 infection. |
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population are Salamanca´s healthcare workers who have overcome SARS-CoV-2 infection, either symptomatic or asymptomatic, either having required hospital admission or not.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passed infection of SARS-CoV-2This is an observational design. Participants have passed infection from SARS-CoV-2 and a cardiac assessment is performed. | Other | Health care workers |
Primary outcome
Myocarditis
Time frame: up to 3 months
Prevalence of myocardial damage suggestive of myocarditis assessed by cardiac magnetic resonance
Pericarditis
Time frame: up to 3 months
Prevalence of pericarditis assessed by clinical criteria
5 secondary outcomes
Atrial fibrillation
Time frame: up to 3 months
Ischemic heart disease
Time frame: up to 3 months
Dilatation of right heart chambers
Time frame: up to 3 months
Valvular hear disease
Time frame: up to 3 months
Rhythm disorders
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV 2 and COVID-19, run by AORTICA Group at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocarditis (time frame: up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.