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Clinical Trials/NCT04624503
NCT04624503
Unknown
N/A

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)

Humanitas Hospital, Italy5 sites in 1 country500 target enrollmentOctober 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Covid19
Sponsor
Humanitas Hospital, Italy
Enrollment
500
Locations
5
Primary Endpoint
All-cause mortality
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
October 1, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Humanitas Hospital, Italy
Responsible Party
Principal Investigator
Principal Investigator

Giulio Stefanini

Prof.

Humanitas Hospital, Italy

Eligibility Criteria

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)

Study Sites (5)

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