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

Cardiovascular Diseases Clinical Trial

— CV-COVID-19  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04359927
• Other study ID #: HCB/2020/0457
• Status: Active, not recruiting
• Start date: April 20, 2020
• Est. completion date: August 31, 2025

Study information

• Verified date: August 2022
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4538
• Est. completion date: August 31, 2025
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Risk Factor
• COVID-19
• Covid19
• Sars-CoV2

Locations

Country	Name	City	State
Spain	Hospital Clínic of Barcelona	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart failure hospitalization	Documented hospital admission due to heart failure	1-year
Other	Pulmonary embolism	Documented by a chest computed tomography	1-year
Other	Cardiac arrhythmias	Documented hospital admission due to any cardiac arrhythmia	1-year
Primary	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	Acute myocardial infarction	Acute myocardial infarction is defined according to the Academic Research Consortium-2.	1-year
Secondary	Stroke	Stroke is defined according to the Academic Research Consortium-2.	1-year