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

Long-term Effects of Coronavirus 2019 Disease on the Cardiovascular System in Patients Who Have Undergone a Diagnostic Nasopharyngeal Swab for SARS-CoV-2. CV COVID-19 Registry

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Covid19; Cardiovascular Risk Factor; Sars-CoV2

Detailed Description

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) that has posed a significant threat to global health. Angiotensin-converting enzyme 2 (ACE2) has been identified as a functional receptor for coronaviruses, including SARS-CoV and SARS-CoV-2. SARS-CoV-2 infection is triggered by the binding of the virus spike protein to ACE2, which is highly expressed in the heart and lungs.

There are multiple connections between COVID-19 and the cardiovascular system. First, COVID-19 patients and pre-existing cardiovascular disease are at increased risk for serious adverse events. Second, the infection has been associated with multiple direct and indirect cardiovascular complications, such as acute myocardial injury, myocarditis, arrhythmias, and thromboembolism. Third, the therapies under investigation for COVID-19 may have cardiovascular side effects. There is clear scientific evidence linking COVID-19 with cardiac damage, with a subsequent impact on mortality from any cause. The reasons for increased mortality in patients with COVID-19 and heart damage are not fully understood.

The long-term prognosis for patients who have had COVID-19 is entirely unknown. Previous experience with SARS-CoV suggests that both the underlying disease and its treatment could be associated with a worse cardiovascular prognosis. In a study of 25 survivors of SARS-CoV, at 12 years of follow-up, altered lipid metabolism was found. Similarly, viral diseases such as influenza A are associated with increased cardiovascular mortality after infection.

For the reasons stated above, the investigators consider that patients who presented COVID-19 have a high risk of long-term cardiovascular adverse events such as cardiac death, myocardial infarction, stroke, heart failure, and cardiac arrhythmias. To test this hypothesis, the investigators aimed to perform a registry of patients who have undergone a diagnostic nasopharyngeal swab for SARS-CoV-2 and determine their long-term cardiovascular outcomes.

• Study Type: Observational
• Enrollment (Actual): 4538

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • Hospital Clinic of Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• ≥ 18 years

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute myocardial infarction	Acute myocardial infarction is defined according to the Academic Research Consortium-2.	1-year
Stroke	Stroke is defined according to the Academic Research Consortium-2.	1-year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart failure hospitalization	Documented hospital admission due to heart failure	1-year
Pulmonary embolism	Documented by a chest computed tomography	1-year
Cardiac arrhythmias	Documented hospital admission due to any cardiac arrhythmia	1-year

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Principal Investigator: Luis Ortega Paz, MD, PhD, Hospital Clinic of Barcelona; Study Director: Salvatore Brugaletta, MD, PhD, Hospital Clinic of Barcelona; Study Chair: Manel Sabaté, MD, PhD, Hospital Clinic of Barcelona

Publications and helpful links

General Publications

• 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.
• 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.
• Arévalos V, Ortega-Paz L, Fernandez-Rodríguez D, Alfonso Jiménez-Díaz V, Rius JB, Campo G, Rodríguez-Santamarta M, de Prado AP, Gómez-Menchero A, Díaz Fernández JF, Scardino C, Gonzalo N, Pernigotti A, Alfonso F, Jesús Amat-Santos I, Silvestro A, Ielasi A, María de la Torre J, Bastidas G, Gómez-Lara J, Sabaté 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Anticipated): August 31, 2025

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Covid19; Cardiovascular Diseases; Sars-CoV2; Cardiovascular death; Cardiovascular Risk Factor
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Cardiovascular Diseases
• Other Study ID Numbers: HCB/2020/0457

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Will be made available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No