Long-term Effects of Coronavirus Disease 2019 on the Cardiovascular System: CV COVID-19 Registry

NCT04359927 | Unknown

• 1 other identifier: HCB/2020/0457
• Study Type: observational
• Target: 4,538
• Locations: 1 country
• Sites: 1

Brief Summary

Patients presenting with the coronavirus-2019 disease (COVID-19) have a very high risk of cardiovascular adverse events, including death from cardiovascular causes. Unfortunately, there are no reliable statistics on the frequency and severity of these complications during the index hospitalization. Moreover, the long-term cardiovascular outcomes of these patients are entirely unknown. The investigators aim to perform a registry of patients who have undergone a diagnostic nasopharyngeal swab for SARS-CoV-2 and determine their long-term cardiovascular outcomes.

Conditions

Sars-CoV2; Covid19; Cardiovascular Diseases; Cardiovascular Risk Factor

Keywords

Sars-CoV2; Covid19; Cardiovascular death; Cardiovascular Diseases; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

• Cardiovascular mortality

  Cardiovascular mortality is defined according to the Academic Research Consortium-2 and will be independently adjudicated by a Clinical Events Committee.

  1-year

Secondary Outcomes (2)

• Acute myocardial infarction

  1-year

• Stroke

  1-year

Other Outcomes (3)

• Heart failure hospitalization

  1-year

• Pulmonary embolism

  1-year

• Cardiac arrhythmias

  1-year

Study Arms (2)

SARS-CoV2/Covid-19 (cases)

Patients with detectable real-time reverse transcriptase-polymerase chain reaction for SARS-CoV2/Covid-19.

No SARS-CoV2/Covid-19 (controls)

Patients with undetectable real-time reverse transcriptase-polymerase chain reaction for SARS-CoV2/Covid-19.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent a nasopharyngeal swab for real-time reverse transcriptase-polymerase chain reaction for SARS-CoV2 in the participating institutions will be included.

You may qualify if:

• ≥ 18 years

You may not qualify if:

• None

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic of Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Related Publications (4)

• Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.

  PMID: 29891620 BACKGROUND

• Zheng YY, Ma YT, Zhang JY, Xie X. COVID-19 and the cardiovascular system. Nat Rev Cardiol. 2020 May;17(5):259-260. doi: 10.1038/s41569-020-0360-5.

  PMID: 32139904 BACKGROUND

• Arevalos V, Ortega-Paz L, Fernandez-Rodriguez D, Alfonso Jimenez-Diaz V, Rius JB, Campo G, Rodriguez-Santamarta M, de Prado AP, Gomez-Menchero A, Diaz Fernandez JF, Scardino C, Gonzalo N, Pernigotti A, Alfonso F, Jesus Amat-Santos I, Silvestro A, Ielasi A, Maria de la Torre J, Bastidas G, Gomez-Lara J, Sabate M, Brugaletta S; CV COVID-19 Registry Investigators. 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.

  PMID: 34324524 BACKGROUND

• Ortega-Paz L, Arevalos V, Fernandez-Rodriguez D, Jimenez-Diaz V, Baneras J, Campo G, Rodriguez-Santamarta M, Diaz JF, Scardino C, Gomez-Alvarez Z, Pernigotti A, Alfonso F, Amat-Santos IJ, Silvestro A, Rampa L, de la Torre Hernandez JM, Bastidas G, Gomez-Lara J, Bikdeli B, Garcia-Garcia HM, Angiolillo DJ, Rodes-Cabau J, Sabate M, Brugaletta S; CV COVID-19 registry investigators. One-year cardiovascular outcomes after coronavirus disease 2019: The cardiovascular COVID-19 registry. PLoS One. 2022 Dec 30;17(12):e0279333. doi: 10.1371/journal.pone.0279333. eCollection 2022.

  PMID: 36583998 DERIVED

MeSH Terms

Conditions

COVID-19; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Luis Ortega Paz, MD, PhD

  Hospital Clínic of Barcelona

  PRINCIPAL INVESTIGATOR

• Salvatore Brugaletta, MD, PhD

  Hospital Clínic of Barcelona

  STUDY DIRECTOR

• Manel Sabaté, MD, PhD

  Hospital Clínic of Barcelona

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Study Start: April 20, 2020
• Primary Completion: December 31, 2021
• Study Completion: August 31, 2025
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)