Sars-CoV2CV-COVID-19NCT04359927
Long-term Effects of Coronavirus Disease 2019 on the Cardiovascular System: CV COVID-19 Registry
An observational study of Sars-CoV2 and Covid19, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sars-CoV2, Covid19, Cardiovascular Diseases
- How many people
- 4,538 participants
- Where
- 1 siteSpain
- Study dates
- 20 Apr 2020to 31 Aug 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥ 18 years
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Keywords
- Sars-CoV2, Covid19, Cardiovascular death, Cardiovascular Diseases, Cardiovascular Risk Factor
- Medical subject headings
- COVID-19, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular mortality
Cardiovascular mortality is defined according to the Academic Research Consortium-2 and will be independently adjudicated by a Clinical Events Committee.
Measured: 1-year
Secondary outcomes (2)
Acute myocardial infarction
Acute myocardial infarction is defined according to the Academic Research Consortium-2.
Measured: 1-year
Stroke
Stroke is defined according to the Academic Research Consortium-2.
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start20 Apr 2020
- Primary completion31 Dec 2021
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 4,538 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Ortega Paz, Hospital Clinic of Barcelona
- Investigators
- Luis Ortega Paz, MD, PhD, Principal investigator, Hospital Clínic of BarcelonaSalvatore Brugaletta, MD, PhD, Study director, Hospital Clínic of BarcelonaManel Sabaté, MD, PhD, Study chair, Hospital Clínic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359927
- Sponsor's protocol ID
- HCB/2020/0457
- Acronym
- CV-COVID-19
- Status last verified
- Aug 2022
- First submitted
- 21 Apr 2020
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will be made available upon request.
Publications
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.
PubMed 29891620Zheng 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.
PubMed 32139904Arevalos V, Ortega-Paz L, Fernandez-Rodriguez D, Alfonso Jimenez-Diaz V, Baneras J, 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.
PubMed 34324524Ortega-Paz L, Arevalos V, Fernandez-Rodriguez D, Jimenez-Diaz V, Baneras J, Campo G, Rodriguez-Santamarta M, Diaz JF, Scardino C, Gomez-Alvarez Z, Pernigotti A, Alfonso F, Amat-Santos IJ, Silvestro A, Rampa L, de la Torre Hernandez JM, Bastidas G, Gomez-Lara J, Bikdeli B, Garcia-Garcia HM, Angiolillo DJ, Rodes-Cabau J, Sabate M, Brugaletta S; CV COVID-19 registry investigators. One-year cardiovascular outcomes after coronavirus disease 2019: The cardiovascular COVID-19 registry. PLoS One. 2022 Dec 30;17(12):e0279333. doi: 10.1371/journal.pone.0279333. eCollection 2022.
PubMed 36583998
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04359927
- Acronym / sponsor ID
- CV-COVID-19 / HCB/2020/0457
- Keywords
- Sars-CoV2, Covid19, Cardiovascular death, Cardiovascular Diseases, Cardiovascular Risk Factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,538 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- ≥ 18 years
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Acute myocardial infarction
Time frame: 1-year
Stroke
Time frame: 1-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Background: PubMed 29891620Garcia-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.
- Background: PubMed 32139904Zheng 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.
- Background: PubMed 34324524Arevalos V, Ortega-Paz L, Fernandez-Rodriguez D, Alfonso Jimenez-Diaz V, Baneras J, 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.
- Derived from this study: PubMed 36583998Ortega-Paz L, Arevalos V, Fernandez-Rodriguez D, Jimenez-Diaz V, Baneras J, Campo G, Rodriguez-Santamarta M, Diaz JF, Scardino C, Gomez-Alvarez Z, Pernigotti A, Alfonso F, Amat-Santos IJ, Silvestro A, Rampa L, de la Torre Hernandez JM, Bastidas G, Gomez-Lara J, Bikdeli B, Garcia-Garcia HM, Angiolillo DJ, Rodes-Cabau J, Sabate M, Brugaletta S; CV COVID-19 registry investigators. One-year cardiovascular outcomes after coronavirus disease 2019: The cardiovascular COVID-19 registry. PLoS One. 2022 Dec 30;17(12):e0279333. doi: 10.1371/journal.pone.0279333. eCollection 2022.
- Individual participant dataSharing planned: No. Will be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Ortega Paz, MD, PhD principal investigator
Hospital Clínic of Barcelona
Salvatore Brugaletta, MD, PhD study director
Hospital Clínic of Barcelona
Manel Sabaté, MD, PhD study chair
Hospital Clínic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sars-CoV2 and Covid19, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular mortality (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04359927, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.