Clinical trial NCT04624503: Prognostic and Clinical Impact of Cardiovascular Involvement in Patients With COVID-19
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Myocardial Injury
Cardiovascular Diseases
Heart Failure
Cardiovascular Morbidity
Keywords: Cardiovascular involvement
COVID-19
Lead sponsor: Humanitas Hospital, Italy
Sponsor class: OTHER
Collaborators: name: Centro Cardiologico Monzino
name: IRCCS Policlinico S. Donato
name: Istituti Clinici Scientifici Maugeri SpA
name: Istituto Auxologico Italiano
First posted: 2020-11-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients for COVID-19.

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.

Eligibility criteria: Inclusion Criteria: patients who were hospitalized for COVID-19

Exclusion Criteria: None.

Primary outcomes:
measure: Cardiovascular mortality
timeFrame: 1 month
measure: Cardiovascular mortality
timeFrame: 6 months
measure: All-cause mortality
timeFrame: 1 month
measure: All-cause mortality
timeFrame: 6 months
measure: Major adverse cardiovascular events (myocardial infarction, cerebrovascular accident, hospitalizations due to heart failure, revascularizations, cardiovascular mortality)
timeFrame: 1 month
measure: Major adverse cardiovascular events (myocardial infarction, cerebrovascular accident, hospitalizations due to heart failure, revascularizations, cardiovascular mortality)
timeFrame: 6 months
Secondary outcomes:
measure: NYHA class
timeFrame: 6 months
measure: Left ventricular systolic function (cardiac magnetic resonance, echocardiography)
timeFrame: 6 months
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: Milan
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
city: Milan
country: Italy
facility: IRCCS Auxologico San Luca
city: Milan
country: Italy
facility: IRCCS San Donato
city: Pavia
country: Italy
facility: IRCCS Istituti Clinici Scientifici Maugeri
Study officials:
affiliation: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: Gianluigi Condorelli, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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, Badalamenti S, Aghemo A, Reimers B, Condorelli G; Humanitas COVID-19 Task Force. Early detection of elevated cardiac biomarkers to optimise risk stratification in patients with COVID-19. Heart. 2020 Oct;106(19):1512-1518. doi: 10.1136/heartjnl-2020-317322. Epub 2020 Aug 14.