An observational study in Sars-CoV2, Covid19 and Cardiovascular Diseases, sponsored by Hospital Clinic of Barcelona. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-25.
Sponsored by Hospital Clinic of Barcelona · Observational
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 4,538 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Hospital Clinic of Barcelona is the lead sponsor of 319 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients with detectable real-time reverse transcriptase-polymerase chain reaction for SARS-CoV2/Covid-19.
Patients with undetectable real-time reverse transcriptase-polymerase chain reaction for SARS-CoV2/Covid-19.
Cardiovascular mortality
Cardiovascular mortality is defined according to the Academic Research Consortium-2 and will be independently adjudicated by a Clinical Events Committee.
Time frame: 1-year
Acute myocardial infarction
Acute myocardial infarction is defined according to the Academic Research Consortium-2.
Time frame: 1-year
Stroke
Stroke is defined according to the Academic Research Consortium-2.
Time frame: 1-year
Heart failure hospitalization
Documented hospital admission due to heart failure
Time frame: 1-year
Pulmonary embolism
Documented by a chest computed tomography
Time frame: 1-year
Cardiac arrhythmias
Documented hospital admission due to any cardiac arrhythmia
Time frame: 1-year
Plan to share: No — Will be made available upon request.
This study is active, not recruiting, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Hospital Clinic of Barcelona