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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
Sponsor:
Information provided by (Responsible Party):
Luis Ortega Paz, Hospital Clinic of Barcelona

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.

Condition or disease
Sars-CoV2 Covid19 Cardiovascular Diseases Cardiovascular Risk Factor

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Group/Cohort
SARS-CoV2/Covid-19 (cases)
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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Acute myocardial infarction [ Time Frame: 1-year ]
    Acute myocardial infarction is defined according to the Academic Research Consortium-2.

  2. Stroke [ Time Frame: 1-year ]
    Stroke is defined according to the Academic Research Consortium-2.


Other Outcome Measures:
  1. Heart failure hospitalization [ Time Frame: 1-year ]
    Documented hospital admission due to heart failure

  2. Pulmonary embolism [ Time Frame: 1-year ]
    Documented by a chest computed tomography

  3. Cardiac arrhythmias [ Time Frame: 1-year ]
    Documented hospital admission due to any cardiac arrhythmia



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • ≥ 18 years

Exclusion Criteria:

  • None

Information from the National Library of Medicine

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


Contacts
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Contact: Luis Ortega, MD, PhD +34 932275400 ext 5519 LGORTEGA@clinic.cat
Contact: Salvatore Brugaletta, MD, PhD +34 932275400 ext 3041 SABRUGAL@clinic.cat

Locations
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Spain
Hospital Clínic of Barcelona Recruiting
Barcelona, Catalonia, Spain, 08036
Contact: Luis Ortega Paz, MD, PhD    +34 932275400 ext 5519    LGORTEGA@clinic.cat   
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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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
Publications:
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Responsible Party: Luis Ortega Paz, Principal Investigator, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT04359927    
Other Study ID Numbers: HCB/2020/0457
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Will be made available upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luis Ortega Paz, Hospital Clinic of Barcelona:
Sars-CoV2
Covid19
Cardiovascular death
Cardiovascular Diseases
Cardiovascular Risk Factor
Additional relevant MeSH terms:
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Cardiovascular Diseases