NCT04413071

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

May 25, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

18 days

First QC Date

May 23, 2020

Last Update Submit

June 13, 2020

Conditions

SARS-CoV 2COVID-19CoronavirusCardiac Magnetic ResonanceMyocarditisCardiac Anomaly

Outcome Measures

Primary Outcomes (2)

  • Myocarditis

    Prevalence of myocardial damage suggestive of myocarditis assessed by cardiac magnetic resonance

    up to 3 months

  • Pericarditis

    Prevalence of pericarditis assessed by clinical criteria

    up to 3 months

Secondary Outcomes (5)

  • Atrial fibrillation

    up to 3 months

  • Ischemic heart disease

    up to 3 months

  • Dilatation of right heart chambers

    up to 3 months

  • Valvular hear disease

    up to 3 months

  • Rhythm disorders

    up to 3 months

Study Arms (1)

Health care workers

Health care workers from the University Hospital of Salamanca who have passed SARS-CoV-2 infection.

Other: Passed infection of SARS-CoV-2

Interventions

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.

Health care workers

Eligibility Criteria

Age18 Years - 71 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Salamanca

Salamanca, 37007, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Analysis of immunity polymorphisms including low-resolution HLA typing and genotyping of KIR genes

MeSH Terms

Conditions

COVID-19Coronavirus InfectionsMyocarditisHeart Defects, Congenital

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesCardiomyopathiesHeart DiseasesCardiovascular DiseasesCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Cardiology Department, Professor of Medicine

Study Record Dates

First Submitted

May 23, 2020

First Posted

June 2, 2020

Study Start

May 25, 2020

Primary Completion

June 12, 2020

Study Completion

June 12, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06

Locations

ES(1)