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

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

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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Arrhythmias, Cardiac / etiology*
  • Arrhythmias, Cardiac / virology
  • COVID-19 / complications*
  • Cardiovascular System / virology*
  • Female
  • Heart Failure / etiology*
  • Heart Failure / virology
  • Humans
  • Italy
  • Male
  • Myocardial Infarction / etiology*
  • Myocardial Infarction / virology
  • Pulmonary Embolism / etiology
  • Pulmonary Embolism / virology
  • Registries
  • Retrospective Studies
  • Spain
  • Stroke / etiology*
  • Stroke / virology
  • Time Factors
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT04359927

Grants and funding

SB. Research grant (COV20/00040) from the Carlos III Institute, Madrid, Spain. https://www.isciii.es/Paginas/Inicio.aspx The funders had and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.