CompletedNot Applicable

Myocardial Injury and Quality of Life After COVID-19

Russia119 participantsStarted 2020-09-16

Plain-language summary

In this observational study follow-up and dynamic observation will be conducted on the participants recovered from pneumonia caused by COVID-19. The main goal is an early diagnosis and detection of myocardial (heart) injury and quality of life in participants recovered from COVID-19 and follow-up in selected participants with present signs of myocarditis and/or myocardial fibrosis.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients of age above 18 years with diagnosed SARS-CoV-2 infection based on the PCR (polymerase chain reaction) and/or quantitative tests of IgM and IgG antibodies in serum; * Pneumonia development confirmed by chest computed tomography; * Negative PCR test for SARS-CoV-2 at the time of inclusion into the study; * Stable patient state allowing outpatient follow-up; * Signed informed consent. Exclusion Criteria: * Absence of convincing data confirming SARS-CoV-2 infection of a participant at the time of inclusion; * Absence of medical records regarding previous treatment of COVID-19; * Low compliance and unwillingness to undergo defined examinations; * Absence of informed consent.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Patients (%) Recovered From COVID-19 With a Decrease in the Global Contractility of the Left and Right Ventricles.

Timeframe: Up to 12 months

Proportion of Patients (%) Recovered From COVID-19 With Signs of Pericardial Effusion.

Timeframe: Up to 12 months

Proportion of Patients (%) Recovered From COVID-19 With Signs of Early and Late Gadolinium Enhancement of Myocardium.

Timeframe: Up to 12 months

Trial details

NCT IDNCT04794062

SponsorVoronezh Regional Clinical Consultative and Diagnostic Center

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2021-10-01

Results submitted2022-05-13

View on ClinicalTrials.gov More COVID-19 trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percentage of Patients (%) Recovered From COVID-19 With a Decrease in the Global Contractility of the Left and Right Ventricles.

Timeframe: Up to 12 months

Proportion of Patients (%) Recovered From COVID-19 With Signs of Pericardial Effusion.

Timeframe: Up to 12 months

Proportion of Patients (%) Recovered From COVID-19 With Signs of Early and Late Gadolinium Enhancement of Myocardium.

Timeframe: Up to 12 months