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)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 500
- Locations
- 5
- Primary Endpoint
- All-cause mortality
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients who were hospitalized for COVID-19
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
All-cause mortality
Time Frame: 6 months
Mortality due to all causes at 6 months after hospitalization
Cardiovascular mortality
Time Frame: 6 months
Mortality due to cardiovascular causes at 6 months after hospitalization
Major adverse cardiovascular events (myocardial infarction, cerebrovascular accident, hospitalizations due to heart failure, revascularizations, cardiovascular mortality)
Time Frame: 6 months
Major adverse cardiovascular events at 6 months after hospitalization
Secondary Outcomes
- Left ventricular systolic function (cardiac magnetic resonance, echocardiography)(6 months)
- NYHA class(6 months)
Investigators
Giulio Stefanini
Prof.
Humanitas Hospital, Italy