Clinical trial NCT04359927: Long-term Effects of Coronavirus Disease 2019 on the Cardiovascular System: CV COVID-19 Registry
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sars-CoV2
Covid19
Cardiovascular Diseases
Cardiovascular Risk Factor
Keywords: Sars-CoV2
Covid19
Cardiovascular death
Cardiovascular Diseases
Cardiovascular Risk Factor
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 4538
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years

Exclusion Criteria:

* None

Primary outcomes:
measure: Cardiovascular mortality
timeFrame: 1-year
Secondary outcomes:
measure: Acute myocardial infarction
timeFrame: 1-year
measure: Stroke
timeFrame: 1-year
Other outcomes:
measure: Heart failure hospitalization
timeFrame: 1-year
measure: Pulmonary embolism
timeFrame: 1-year
measure: Cardiac arrhythmias
timeFrame: 1-year
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic of Barcelona
state: Catalonia
Study officials:
affiliation: Hospital Clínic of Barcelona
name: Luis Ortega Paz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínic of Barcelona
name: Salvatore Brugaletta, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Clínic of Barcelona
name: Manel Sabaté, MD, PhD
role: STUDY_CHAIR
References:
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.
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.
citation: 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.