Heart Failure Clinical Trial
— CARDIO-COVIDOfficial 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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | October 1, 2021 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: patients who were hospitalized for COVID-19 Exclusion Criteria: None. |
Country | Name | City | State |
---|---|---|---|
Italy | Centro Cardiologico Monzino | Milan | |
Italy | IRCCS Auxologico San Luca | Milan | |
Italy | IRCCS San Donato | Milan | |
Italy | IRCCS Istituti Clinici Scientifici Maugeri | Pavia | |
Italy | Humanitas Research Hospital | Rozzano | Milan |
Lead Sponsor | Collaborator |
---|---|
Humanitas Hospital, Italy | Centro Cardiologico Monzino, IRCCS Policlinico S. Donato, Istituti Clinici Scientifici Maugeri SpA, Istituto Auxologico Italiano |
Italy,
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, Badalament — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiovascular mortality | Mortality due to cardiovascular causes at 1 month after hospitalization | 1 month | |
Primary | Cardiovascular mortality | Mortality due to cardiovascular causes at 6 months after hospitalization | 6 months | |
Primary | All-cause mortality | Mortality due to all causes at 1 month after hospitalization | 1 month | |
Primary | All-cause mortality | Mortality due to all causes at 6 months after hospitalization | 6 months | |
Primary | 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 | 1 month | |
Primary | 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 | 6 months | |
Secondary | NYHA class | NYHA functional class: from I (no limitation of physical activity) to IV (severe limitation with symptoms at rest) | 6 months | |
Secondary | Left ventricular systolic function (cardiac magnetic resonance, echocardiography) | Left ventricular systolic function evaluated with multimodality imaging | 6 months |
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