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

November 9, 2020 updated by: Giulio Stefanini, Humanitas Hospital, Italy

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)

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy
        • Recruiting
        • Centro Cardiologico Monzino
        • Contact:
          • Piergiuseppe Agostoni, Prof.
      • Milan, Italy
        • Recruiting
        • IRCCS Auxologico San Luca
        • Contact:
          • Luigi Badano, Prof.
      • Milan, Italy
        • Recruiting
        • IRCCS San Donato
        • Contact:
          • Marco Guazzi, Prof
      • Pavia, Italy
        • Recruiting
        • IRCCS Istituti Clinici Scientifici Maugeri
        • Contact:
          • Sivlia Priori, Prof.ssa
    • Milan
      • Rozzano, Milan, Italy, 20089
        • Recruiting
        • Humanitas Research Hospital
        • Contact:
        • Principal Investigator:
          • Giulio Stefanini, Prof
        • Principal Investigator:
          • Gianluigi Condorelli, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized patients for COVID-19.

Description

Inclusion Criteria: patients who were hospitalized for COVID-19

Exclusion Criteria: None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular mortality
Time Frame: 1 month
Mortality due to cardiovascular causes at 1 month after hospitalization
1 month
Cardiovascular mortality
Time Frame: 6 months
Mortality due to cardiovascular causes at 6 months after hospitalization
6 months
All-cause mortality
Time Frame: 1 month
Mortality due to all causes at 1 month after hospitalization
1 month
All-cause mortality
Time Frame: 6 months
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)
Time Frame: 1 month
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)
Time Frame: 6 months
Major adverse cardiovascular events at 6 months after hospitalization
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Humanitas Hospital, Italy

Collaborators

IRCCS Policlinico S. Donato
Istituto Auxologico Italiano
Istituti Clinici Scientifici Maugeri SpA
Centro Cardiologico Monzino

Investigators

  • Principal Investigator: Gianluigi Condorelli, Prof, Humanitas Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

October 17, 2020

First Submitted That Met QC Criteria

November 9, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARDIOCOVID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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