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

NCT ID: NCT04359927

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 4538 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-20
• Study Completion Date: 2025-08-31

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.

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

SARS-CoV2/Covid-19 (cases)

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

No interventions assigned to this group

No SARS-CoV2/Covid-19 (controls)

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• ≥ 18 years

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Luis Ortega Paz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luis Ortega Paz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínic of Barcelona

Salvatore Brugaletta, MD, PhD

Role: STUDY_DIRECTOR

Hospital Clínic of Barcelona

Manel Sabaté, MD, PhD

Role: STUDY_CHAIR

Hospital Clínic of Barcelona

Locations

Hospital Clínic of Barcelona

Barcelona, Catalonia, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 29891620 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32139904 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34324524 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36583998 (View on PubMed)

Other Identifiers

HCB/2020/0457

Identifier Type: -

Identifier Source: org_study_id