Covid19NCT04501822
One-year Cardiac Follow-up of Patients With COVID-19 Pneumonia
An observational study of Covid19 and Cardiac Complication, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial summary
The primary objective of the study is to assess the cardiac status of COVID-19 pneumonia patients during 1 year after discharge Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Cardiac Complication
- What is being tested?
- Evaluation of clinical, instrumental and laboratory diagnostics tests
- How many people
- 380 participants
- Where
- 1 siteRussia
- Study dates
- 19 Jul 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study includes men and women ≥18 years old with documented COVID-19 pneumonia
Who may be able to join
- -Patients with documented COVID-19 pneumonia
Who cannot join
- Patients with cancer
- Impossible to follow up
Trial locations and contacts
1 site in 1 country.
Russia1 site
Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science
Tyumen, 625026
About this study
The primary objective of the study is to assess the cardiac status of COVID-19 pneumonia patients during 1 year after discharge
Read the 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.
- Conditions
- Covid19, Cardiac Complication
- Being tested
- Evaluation of clinical, instrumental and laboratory diagnostics tests
- Keywords
- Covid19, Cardiovascular Disease, Echocardiography
- Medical subject headings
- COVID-19, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of clinical, instrumental and laboratory diagnostics testsDiagnostic test
During follow-up visits patients undergo clinical, instrumental and laboratory diagnostics tests
| Study group | Role | What they receive |
|---|---|---|
| Covid19 pneumonia patients | The study includes men and women ≥18 years old with documented COVID-19 pneumonia Receives: Diagnostic Test: Evaluation of clinical, instrumental and laboratory diagnostics tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic assessment of cardiac function
Echocardiographic assessment of global strain parameters at 3 and 12 months after discharge
Measured: up to one year
Secondary outcomes (7)
МАССЕ
Major adverse cardiac and cerebrovascular events: cardiac death, myocardial infarction, or stroke at 3 and 12 months after discharge
Measured: up to one year
Quantitative analysis of parenchymal lung damage
Describe the parenchymal lung damage through a quantitative analysis with chest CT at 3 and 12 months after discharge
Measured: up to one year
Functional exercises capacity assessment
Six-min walk test at 3 and 12 months after discharge
Measured: up to one year
Evaluation of renal function
Measure of creatinine clearance at 3 and 12 months after discharge
Measured: up to one year
Evaluation of inflammation
Analysis for C-reactive protein at 3 and 12 months after discharge
Measured: up to one year
Evaluation of coagulation abnormality
Analysis for activated clotting time at 3 and 12 months
Measured: up to one year
Evaluation of quality of life in first year after discharge
Assessment of the Short Form Health Survey (SF36) at 3 and 12 months after discharge
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start19 Jul 2020
- Primary completion19 Jul 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Yaroslavskaya, PhD, Principal investigator, Tyumen Cardiology Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501822
- Sponsor's protocol ID
- TCRC-159 (COVID)
- Status last verified
- Jun 2026
- First submitted
- 28 Jul 2020
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-year Cardiac Follow-up of Patients With COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04501822
- Acronym / sponsor ID
- TCRC-159 (COVID)
- Conditions
- Covid19, Cardiac Complication
- Keywords
- Covid19, Cardiovascular Disease, Echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 19 Jul 2020 (actual)
- Primary completion
- 19 Jul 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to assess the cardiac status of COVID-19 pneumonia patients during 1 year after discharge
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covid19 pneumonia patients | – | Diagnostic Test: Evaluation of clinical, instrumental and laboratory diagnostics testsThe study includes men and women ≥18 years old with documented COVID-19 pneumonia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study includes men and women ≥18 years old with documented COVID-19 pneumonia
Key inclusion criteria (1 listed)
- -Patients with documented COVID-19 pneumonia
Key exclusion criteria (2 listed)
- Patients with cancer
- Impossible to follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of clinical, instrumental and laboratory diagnostics testsDuring follow-up visits patients undergo clinical, instrumental and laboratory diagnostics tests | Diagnostic test | Covid19 pneumonia patients |
Primary outcome
Echocardiographic assessment of cardiac function
Time frame: up to one year
Echocardiographic assessment of global strain parameters at 3 and 12 months after discharge
7 secondary outcomes
МАССЕ
Time frame: up to one year
Quantitative analysis of parenchymal lung damage
Time frame: up to one year
Functional exercises capacity assessment
Time frame: up to one year
Evaluation of renal function
Time frame: up to one year
Evaluation of inflammation
Time frame: up to one year
Evaluation of coagulation abnormality
Time frame: up to one year
Evaluation of quality of life in first year after discharge
Time frame: up to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Yaroslavskaya, PhD principal investigator
Tyumen Cardiology Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Cardiac Complication, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echocardiographic assessment of cardiac function (time frame: up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.