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

NCT ID: NCT04624503

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-10-01

Brief Summary

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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

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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.

Conditions

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Covid19 Myocardial Injury Cardiovascular Diseases Heart Failure Cardiovascular Morbidity

Keywords

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Cardiovascular involvement COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: patients who were hospitalized for COVID-19

Exclusion Criteria: None.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Cardiologico Monzino

OTHER

Sponsor Role collaborator

IRCCS Policlinico S. Donato

OTHER

Sponsor Role collaborator

Istituti Clinici Scientifici Maugeri SpA

OTHER

Sponsor Role collaborator

Istituto Auxologico Italiano

OTHER

Sponsor Role collaborator

Humanitas Hospital, Italy

OTHER

Sponsor Role lead

Responsible Party

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Giulio Stefanini

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gianluigi Condorelli, Prof

Role: PRINCIPAL_INVESTIGATOR

Humanitas Research Hospital IRCCS, Rozzano-Milan

Locations

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Humanitas Research Hospital

Rozzano, Milan, Italy

Site Status RECRUITING

Centro Cardiologico Monzino

Milan, , Italy

Site Status RECRUITING

IRCCS Auxologico San Luca

Milan, , Italy

Site Status RECRUITING

IRCCS San Donato

Milan, , Italy

Site Status RECRUITING

IRCCS Istituti Clinici Scientifici Maugeri

Pavia, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giulio Stefanini, Prof.

Role: CONTACT

Phone: 0282247384

Email: [email protected]

Facility Contacts

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Giulio Stefanini, Prof

Role: primary

Piergiuseppe Agostoni, Prof.

Role: primary

Luigi Badano, Prof.

Role: primary

Marco Guazzi, Prof

Role: primary

Sivlia Priori, Prof.ssa

Role: primary

References

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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.

Reference Type RESULT
PMID: 32817312 (View on PubMed)

Other Identifiers

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CARDIOCOVID

Identifier Type: -

Identifier Source: org_study_id