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

• Conditions: Covid19; Myocardial Injury; Cardiovascular Diseases; Cardiovascular Morbidity; Heart Failure

• Registration Number: NCT04624503
• Lead Sponsor: Humanitas Hospital, Italy

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 Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2020-10-17
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-09
• Last Update Submitted: 2020-11-09
• Study First Posted: 2020-11-10
• Last Update Posted: 2020-11-10
• Primary Completion: 2021-06-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

patients who were hospitalized for COVID-19

Exclusion Criteria

None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality	6 months	Mortality due to all causes at 6 months after hospitalization
Cardiovascular mortality	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)	6 months	Major adverse cardiovascular events at 6 months after hospitalization

Secondary Outcome Measures

Name	Time	Method
Left ventricular systolic function (cardiac magnetic resonance, echocardiography)	6 months	Left ventricular systolic function evaluated with multimodality imaging
NYHA class	6 months	NYHA functional class: from I (no limitation of physical activity) to IV (severe limitation with symptoms at rest)

Trial Locations

Locations (5)

Centro Cardiologico Monzino; 🇮🇹 Milan, Italy

IRCCS Istituti Clinici Scientifici Maugeri; 🇮🇹 Pavia, Italy

IRCCS Auxologico San Luca; 🇮🇹 Milan, Italy

Humanitas Research Hospital; 🇮🇹 Rozzano, Milan, Italy

IRCCS San Donato; 🇮🇹 Milan, Italy