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Covid19CARDIO-COVIDNCT04624503

Prognostic and Clinical Impact of Cardiovascular Involvement in Patients With COVID-19

An observational study of Covid19 and Myocardial Injury, run by Humanitas Hospital, Italy at 5 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

COVID-19 infection has been associated with numerous cardiac manifestations. Indeed, SARS-CoV-2 may impact on cardiovascular system through a direct myocardial infection or a secondary cardiac involvement due to hypoxia or metabolic supply-demand imbalance or prothrombotic inflammatory state. Read more about this study

Who is it for?
Ages 18 to 85 years
How many people
500 participants
Where
5 sitesItaly
Study dates
1 Oct 2020to 1 Oct 2021
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Hospitalized patients for COVID-19.

Inclusion Criteria: patients who were hospitalized for COVID-19

Exclusion Criteria: None.

Trial locations and contacts

5 sites in 1 country.

Giulio Stefanini, Prof. contact

0282247384

giulio.stefanini@hunimed.eu

5 sites in 1 country

Italy5 sites, 5 recruiting

  • Centro Cardiologico Monzino

    Milan

    Piergiuseppe Agostoni, Prof.

    Recruiting

  • IRCCS Auxologico San Luca

    Milan

    Luigi Badano, Prof.

    Recruiting

  • IRCCS San Donato

    Milan

    Marco Guazzi, Prof

    Recruiting

  • IRCCS Istituti Clinici Scientifici Maugeri

    Pavia

    Sivlia Priori, Prof.ssa

    Recruiting

  • Humanitas Research Hospital

    Rozzano, Milan, 20089

    Giulio Stefanini, Prof, 0282247384, giulio.stefanini@hunimed.eu

    Gianluigi Condorelli, Prof

    Recruiting

Other trials in Italy

About this study

Official title: Prognostic and Clinical Impact of Cardiovascular Involvement in Patients With COVID-19 (Rilevanza Clinica e Prognostica Del Coinvolgimento Cardiovascolare Nei Pazienti Affetti da COVID-19)

COVID-19 infection has been associated with numerous cardiac manifestations. Indeed, SARS-CoV-2 may impact on cardiovascular system through a direct myocardial infection or a secondary cardiac involvement due to hypoxia or metabolic supply-demand imbalance or prothrombotic inflammatory state. As a consequence of and besides acute myocardial damages, COVID-19 could also determine chronic cardiovascular consequences, with a significant impact on long-term prognosis, quality of life and functional capacity of COVID-19 survivors.

On this basis, we aim to define the clinical and prognostic effects of myocardial involvement in COVID-19 patients.

Read the detailed description

COVID-19 infection has been associated with numerous cardiac manifestations. Indeed, SARS-CoV-2 may impact on cardiovascular system through a direct myocardial infection or a secondary cardiac involvement due to hypoxia or metabolic supply-demand imbalance or prothrombotic inflammatory state. As a consequence of and besides acute myocardial damages, COVID-19 could also determine chronic cardiovascular consequences, with a significant impact on long-term prognosis, quality of life and functional capacity of COVID-19 survivors.

On this basis, we aim to define the clinical and prognostic effects of myocardial involvement in COVID-19 patients, with a 1-month and 6-month follow-up composed of clinical evaluation, electrocardiogram, trans-thoracic echocardiogram, cardiovascular magnetic resonance, chest computerized tomography scan and cardiopulmonary exercise test.

Keywords
Cardiovascular involvement, COVID-19
Medical subject headings
COVID-19, Cardiovascular Diseases, Heart Failure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiovascular mortality

    Mortality due to cardiovascular causes at 1 month after hospitalization

    Measured: 1 month

  2. Cardiovascular mortality

    Mortality due to cardiovascular causes at 6 months after hospitalization

    Measured: 6 months

  3. All-cause mortality

    Mortality due to all causes at 1 month after hospitalization

    Measured: 1 month

  4. All-cause mortality

    Mortality due to all causes at 6 months after hospitalization

    Measured: 6 months

  5. Major adverse cardiovascular events (myocardial infarction, cerebrovascular accident, hospitalizations due to heart failure, revascularizations, cardiovascular mortality)

    Major adverse cardiovascular events at 1 month after hospitalization

    Measured: 1 month

  6. Major adverse cardiovascular events (myocardial infarction, cerebrovascular accident, hospitalizations due to heart failure, revascularizations, cardiovascular mortality)

    Major adverse cardiovascular events at 6 months after hospitalization

    Measured: 6 months

Secondary outcomes (2)

  1. NYHA class

    NYHA functional class: from I (no limitation of physical activity) to IV (severe limitation with symptoms at rest)

    Measured: 6 months

  2. Left ventricular systolic function (cardiac magnetic resonance, echocardiography)

    Left ventricular systolic function evaluated with multimodality imaging

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2020
  2. Study start1 Oct 2020
  3. Primary completion1 Jun 2021 (estimated)
  4. Study completion1 Oct 2021 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04624503
Sponsor's protocol ID
CARDIOCOVID
Acronym
CARDIO-COVID
Status last verified
Nov 2020
First submitted
17 Oct 2020
Last updated
10 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Stefanini GG, Chiarito M, Ferrante G, Cannata F, Azzolini E, Viggiani G, De Marco A, Briani M, Bocciolone M, Bragato R, Corrada E, Gasparini GL, Marconi M, Monti L, Pagnotta PA, Panico C, Pini D, Regazzoli D, My I, Kallikourdis M, Ciccarelli M, Badalamenti S, Aghemo A, Reimers B, Condorelli G; Humanitas COVID-19 Task Force. Early detection of elevated cardiac biomarkers to optimise risk stratification in patients with COVID-19. Heart. 2020 Oct;106(19):1512-1518. doi: 10.1136/heartjnl-2020-317322. Epub 2020 Aug 14.

    PubMed 32817312

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and Myocardial Injury, run by Humanitas Hospital, Italy at 5 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Italy. 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?

Contact Giulio Stefanini, Prof. (0282247384, giulio.stefanini@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovascular mortality (time frame: 1 month). The study lists 6 primary outcomes in all. 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 NCT04624503, which also lists 1 linked publication.

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 10 Nov 2020.

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