NCT04624503

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

October 17, 2020

Last Update Submit

November 9, 2020

Conditions

Covid19Myocardial InjuryCardiovascular DiseasesHeart FailureCardiovascular Morbidity

Keywords

Cardiovascular involvementCOVID-19

Outcome Measures

Primary Outcomes (6)

  • Cardiovascular mortality

    Mortality due to cardiovascular causes at 1 month after hospitalization

    1 month

  • Cardiovascular mortality

    Mortality due to cardiovascular causes at 6 months after hospitalization

    6 months

  • All-cause mortality

    Mortality due to all causes at 1 month after hospitalization

    1 month

  • All-cause mortality

    Mortality due to all causes at 6 months after hospitalization

    6 months

  • 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

  • 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 Outcomes (2)

  • NYHA class

    6 months

  • Left ventricular systolic function (cardiac magnetic resonance, echocardiography)

    6 months

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized patients for COVID-19.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

RECRUITING

Centro Cardiologico Monzino

Milan, Italy

RECRUITING

IRCCS Auxologico San Luca

Milan, Italy

RECRUITING

IRCCS San Donato

Milan, Italy

RECRUITING

IRCCS Istituti Clinici Scientifici Maugeri

Pavia, Italy

RECRUITING

Related 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, 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.

    PMID: 32817312RESULT

MeSH Terms

Conditions

COVID-19Cardiovascular DiseasesHeart Failure

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesHeart Diseases

Study Officials

  • Gianluigi Condorelli, Prof

    Humanitas Research Hospital IRCCS, Rozzano-Milan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giulio Stefanini, Prof.

CONTACT

0282247384giulio.stefanini@hunimed.eu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

October 17, 2020

First Posted

November 10, 2020

Study Start

October 1, 2020

Primary Completion

June 1, 2021

Study Completion

October 1, 2021

Last Updated

November 10, 2020

Record last verified: 2020-11

Locations

IT(5)