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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04624503
Other study ID # CARDIOCOVID
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date October 1, 2021

Study information

Verified date November 2020
Source Humanitas Hospital, Italy
Contact Giulio Stefanini, Prof.
Phone 0282247384
Email giulio.stefanini@hunimed.eu
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

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.

Study Design


Locations

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

Sponsors (5)

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

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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

Outcome

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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