One-year Cardiac Follow-up of Patients With COVID-19 Pneumonia

April 26, 2022 updated by: Tomsk National Research Medical Center of the Russian Academy of Sciences
The primary objective of the study is to assess the cardiac status of COVID-19 pneumonia patients during 1 year after discharge

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although COVID-19 manifests in most cases with respiratory symptoms, cardiovascular abnormalities is common in hospitalized patients. Patients with cardiovascular risk factors or established disease appear to have a worse prognosis. Myocardial dysfunction could be a direct manifestation of COVID-19. The investigators hypothesize that subjects after COVID-19 pneumonia present myocardial and vascular remodeling during 1 year after discharge, even in the absence of prior cardiovascular disease.

Study Type

Observational

Enrollment (Actual)

380

Contacts and Locations

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

Study Locations

  • Russian Federation
      • Tyumen, Russian Federation, 625026
        • Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study includes men and women ≥18 years old with documented COVID-19 pneumonia

Description

Inclusion Criteria:

-Patients with documented COVID-19 pneumonia

Exclusion Criteria:

  • Patients with cancer
  • Impossible to follow up

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Covid19 pneumonia patients
The study includes men and women ≥18 years old with documented COVID-19 pneumonia
Diagnostic test: Evaluation of clinical, instrumental and laboratory diagnostics tests
During follow-up visits patients undergo clinical, instrumental and laboratory diagnostics tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Echocardiographic assessment of cardiac function
Time Frame: up to one year
Echocardiographic assessment of global strain parameters at 3 and 12 months after discharge
up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
МАССЕ
Time Frame: up to one year
Major adverse cardiac and cerebrovascular events: cardiac death, myocardial infarction, or stroke at 3 and 12 months after discharge
up to one year
Quantitative analysis of parenchymal lung damage
Time Frame: up to one year
Describe the parenchymal lung damage through a quantitative analysis with chest CT at 3 and 12 months after discharge
up to one year
Functional exercises capacity assessment
Time Frame: up to one year
Six-min walk test at 3 and 12 months after discharge
up to one year
Evaluation of renal function
Time Frame: up to one year
Measure of creatinine clearance at 3 and 12 months after discharge
up to one year
Evaluation of inflammation
Time Frame: up to one year
Analysis for C-reactive protein at 3 and 12 months after discharge
up to one year
Evaluation of coagulation abnormality
Time Frame: up to one year
Analysis for activated clotting time at 3 and 12 months
up to one year
Evaluation of quality of life in first year after discharge
Time Frame: up to one year
Assessment of the Short Form Health Survey (SF36) at 3 and 12 months after discharge
up to one year

Collaborators and Investigators

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

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Investigators

  • Principal Investigator: Elena Yaroslavskaya, PhD, Tyumen Cardiology Research Center

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)

July 19, 2020

Primary Completion (ACTUAL)

July 19, 2021

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

July 28, 2020

First Submitted That Met QC Criteria

August 5, 2020

First Posted (ACTUAL)

August 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 26, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCRC-COVID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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