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

Heart Failure Clinical Trial

— CARDIO-COVID  

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04624503
• Other study ID #: CARDIOCOVID
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

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

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