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Clinical Trial
. 2021 Jul 29;16(7):e0255263.
doi: 10.1371/journal.pone.0255263. eCollection 2021.

Long-term effects of coronavirus disease 2019 on the cardiovascular system, CV COVID registry: A structured summary of a study protocol

Victor Arévalos  1 , Luis Ortega-Paz  1 , Diego Fernandez-Rodríguez  2 , Víctor Alfonso Jiménez-Díaz  3 , Jordi Bañeras Rius  4 , Gianluca Campo  5 , Miguel Rodríguez-Santamarta  6 , Armando Pérez de Prado  6 , Antonio Gómez-Menchero  7 , José Francisco Díaz Fernández  7 , Claudia Scardino  8 , Nieves Gonzalo  9 , Alberto Pernigotti  10 , Fernando Alfonso  11 , Ignacio Jesús Amat-Santos  12 , Antonio Silvestro  13 , Alfonso Ielasi  14 , José María de la Torre  15 , Gabriela Bastidas  16 , Josep Gómez-Lara  17 , Manel Sabaté  1 , Salvatore Brugaletta  1 ; CV COVID-19 Registry Investigators
Affiliations
Clinical Trial

Long-term effects of coronavirus disease 2019 on the cardiovascular system, CV COVID registry: A structured summary of a study protocol

Victor Arévalos et al. PLoS One. .

Abstract

Background: Patients presenting with the coronavirus-2019 disease (COVID-19) may have a high risk of cardiovascular adverse events, including death from cardiovascular causes. The long-term cardiovascular outcomes of these patients are entirely unknown. We aim to perform a registry of patients who have undergone a diagnostic nasopharyngeal swab for SARS-CoV-2 and to determine their long-term cardiovascular outcomes.

Study and design: This is a multicenter, observational, retrospective registry to be conducted at 17 centers in Spain and Italy (ClinicalTrials.gov number: NCT04359927). Consecutive patients older than 18 years, who underwent a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) for SARS-CoV2 in the participating institutions, will be included since March 2020, to August 2020. Patients will be classified into two groups, according to the results of the RT-PCR: COVID-19 positive or negative. The primary outcome will be cardiovascular mortality at 1 year. The secondary outcomes will be acute myocardial infarction, stroke, heart failure hospitalization, pulmonary embolism, and serious cardiac arrhythmias, at 1 year. Outcomes will be compared between the two groups. Events will be adjudicated by an independent clinical event committee.

Conclusion: The results of this registry will contribute to a better understanding of the long-term cardiovascular implications of the COVID19.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Timeline of the study.
Inclusion of the patients will be since March to August 2020. Analysis of the clinical outcomes will be performed in August 2021.
See this image and copyright information in PMC

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