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Clinical Trials/NCT04359927
NCT04359927
Active, not recruiting
Not Applicable

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

Hospital Clinic of Barcelona1 site in 1 country4,538 target enrollmentApril 20, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sars-CoV2
Sponsor
Hospital Clinic of Barcelona
Enrollment
4538
Locations
1
Primary Endpoint
Cardiovascular mortality
Status
Active, not recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2020
End Date
August 31, 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Luis Ortega Paz

Principal Investigator

Hospital Clinic of Barcelona

Eligibility Criteria

Inclusion Criteria

  • ≥ 18 years

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Cardiovascular mortality

Time Frame: 1-year

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

Secondary Outcomes

  • Acute myocardial infarction(1-year)
  • Stroke(1-year)

Study Sites (1)

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