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

Completed

• Conditions: Cardiac Complication; Covid19
• Interventions: Diagnostic Test: Evaluation of clinical, instrumental and laboratory diagnostics tests

• Registration Number: NCT04501822
• Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

Brief Summary

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 Timeline

• Study Start: 2020-07-19
• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-06
• Primary Completion: 2021-07-19
• Study Completion: 2021-12-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

-Patients with documented COVID-19 pneumonia

Exclusion Criteria

• Patients with cancer
• Impossible to follow up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Covid19 pneumonia patients	Evaluation of clinical, instrumental and laboratory diagnostics tests	The study includes men and women ≥18 years old with documented COVID-19 pneumonia

Primary Outcome Measures

Name	Time	Method
Echocardiographic assessment of cardiac function	up to one year	Echocardiographic assessment of global strain parameters at 3 and 12 months after discharge

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science; 🇷🇺 Tyumen, Russian Federation