Long-term Effects of Coronavirus Disease 2019 on the Cardiovascular System: CV COVID-19 Registry (CV-COVID-19)
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|ClinicalTrials.gov Identifier: NCT04359927|
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : May 7, 2020
|Condition or disease|
|Sars-CoV2 Covid19 Cardiovascular Diseases Cardiovascular Risk Factor|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||10000 participants|
|Target Follow-Up Duration:||1 Year|
|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|
|Actual Study Start Date :||April 20, 2020|
|Estimated Primary Completion Date :||August 31, 2021|
|Estimated Study Completion Date :||August 31, 2025|
Patients with detectable real-time reverse transcriptase-polymerase chain reaction for SARS-CoV2/Covid-19.
No SARS-CoV2/Covid-19 (controls)
Patients with undetectable real-time reverse transcriptase-polymerase chain reaction for SARS-CoV2/Covid-19.
- 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.
- Acute myocardial infarction [ Time Frame: 1-year ]Acute myocardial infarction is defined according to the Academic Research Consortium-2.
- Stroke [ Time Frame: 1-year ]Stroke is defined according to the Academic Research Consortium-2.
- Heart failure hospitalization [ Time Frame: 1-year ]Documented hospital admission due to heart failure
- Pulmonary embolism [ Time Frame: 1-year ]Documented by a chest computed tomography
- Cardiac arrhythmias [ Time Frame: 1-year ]Documented hospital admission due to any cardiac arrhythmia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359927
|Contact: Luis Ortega, MD, PhD||+34 932275400 ext 5519||LGORTEGA@clinic.cat|
|Contact: Salvatore Brugaletta, MD, PhD||+34 932275400 ext 3041||SABRUGAL@clinic.cat|
|Hospital Clínic of Barcelona||Recruiting|
|Barcelona, Catalonia, Spain, 08036|
|Contact: Luis Ortega Paz, MD, PhD +34 932275400 ext 5519 LGORTEGA@clinic.cat|
|Principal Investigator:||Luis Ortega Paz, MD, PhD||Hospital Clínic of Barcelona|
|Study Director:||Salvatore Brugaletta, MD, PhD||Hospital Clínic of Barcelona|
|Study Chair:||Manel Sabaté, MD, PhD||Hospital Clínic of Barcelona|