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

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)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04624503
Acronym
CARDIO-COVID
Enrollment
500
Registered
2020-11-10
Start date
2020-10-01
Completion date
2021-10-01
Last updated
2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Cardiovascular Morbidity, Covid19, Heart Failure, Myocardial Injury

Keywords

Cardiovascular involvement, COVID-19

Brief 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. 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.

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.

Interventions

None listed

Sponsors

Centro Cardiologico Monzino
CollaboratorOTHER
IRCCS Policlinico S. Donato
CollaboratorOTHER
Istituti Clinici Scientifici Maugeri SpA
CollaboratorOTHER
Istituto Auxologico Italiano
CollaboratorOTHER
Humanitas Hospital, Italy
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

patients who were hospitalized for COVID-19

Exclusion criteria

None.

Design outcomes

Primary

MeasureTime frameDescription
Cardiovascular mortality1 monthMortality due to cardiovascular causes at 1 month after hospitalization
All-cause mortality1 monthMortality due to all causes at 1 month after hospitalization
Major adverse cardiovascular events (myocardial infarction, cerebrovascular accident, hospitalizations due to heart failure, revascularizations, cardiovascular mortality)1 monthMajor adverse cardiovascular events at 1 month after hospitalization

Secondary

MeasureTime frameDescription
NYHA class6 monthsNYHA functional class: from I (no limitation of physical activity) to IV (severe limitation with symptoms at rest)
Left ventricular systolic function (cardiac magnetic resonance, echocardiography)6 monthsLeft ventricular systolic function evaluated with multimodality imaging

Countries

Italy

Contacts

Primary ContactGiulio Stefanini, Prof.
giulio.stefanini@hunimed.eu0282247384

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026