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NCT04794062

Myocardial Injury and Quality of Life After COVID-19

Completed Results posted Last updated 19 November 2024
What this trial tests

trial in COVID-19 in 119 participants. Completed in 31 December 2021.

Timeline
16 September 2020
Primary endpoint
1 October 2021
31 December 2021

Quick facts

Lead sponsorVoronezh Regional Clinical Consultative and Diagnostic Center
StatusCompleted
Study typeOBSERVATIONAL
Enrollment119
Start date16 September 2020
Primary completion1 October 2021
Estimated completion31 December 2021
Sites1 location across Russia

Conditions studied

Sponsor

Voronezh Regional Clinical Consultative and Diagnostic Center

Who can join

18 and older, any sex, with COVID-19 or Myocardial Injury. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Patients (%) Recovered From COVID-19 With a Decrease in the Global Contractility of the Left and Right Ventricles. Primary · Up to 12 months

Decrease of the left ventricle ejection fraction below 57% in men and women or decrease of the right ventricle ejection fraction below 52% in men and 51% in women.

GroupValue95% CI
Patients Recovered From COVID-1919
Patients Recovered From COVID-1939
Patients Recovered From COVID-1948
Proportion of Patients (%) Recovered From COVID-19 With Signs of Pericardial Effusion. Primary · Up to 12 months

Presence of pericardial effusion, i.e., presence of free echocardiographic spaces between the pericardial layers during diastole with pericardial layer thickness more than 4mm.

Pericardial effusion
GroupValue95% CI
Patients Recovered From COVID-1927
No pericardial effusion
GroupValue95% CI
Patients Recovered From COVID-1979
Proportion of Patients (%) Recovered From COVID-19 With Signs of Early and Late Gadolinium Enhancement of Myocardium. Primary · Up to 12 months

Presence of early and late gadolinium enhancement of myocardium on cardiac MRI.

Presence of early and late gadolinium enhancement of myocardium.
GroupValue95% CI
Patients Recovered From COVID-1928
No early and late gadolinium enhancement of myocardium.
GroupValue95% CI
Patients Recovered From COVID-1978
Evaluation of Quality of Life of the Patients Recovered From the COVID-19 by the Duke Activity Status Index. Secondary · At the time of enrollment, but analysis of quality of life criteria was additionally decided to be performed as a separate sub-study.

The Duke Activity Status Index is an assessment tool used to evaluate the functional capacity of patients with cardiovascular disease. Positive responses are summed up to get a total score, which ranges from 0 to 58.2. Higher scores would indicate a higher functional capacity.

GroupValue95% CI
Patients Recovered From COVID-1931.8± 12.3

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Cardiac involvement in the long-term implications of COVID-19.
    Satterfield BA, Bhatt DL, Gersh BJ. · · 2022 · cited 101× · PMID 34686843 · DOI 10.1038/s41569-021-00631-3
  2. The Pathogenesis and Long-Term Consequences of COVID-19 Cardiac Injury.
    Siripanthong B, Asatryan B, Hanff TC, Chatha SR, et al · · 2022 · cited 73× · PMID 35165665 · DOI 10.1016/j.jacbts.2021.10.011

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04794062.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing