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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04501822
• Other study ID #: TCRC-COVID
• Status: Completed
• Start date: July 19, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of the study is to assess the cardiac status of COVID-19 pneumonia patients during 1 year after discharge

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: December 31, 2021
• Est. primary completion date: July 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-Patients with documented COVID-19 pneumonia

Exclusion Criteria:

• Patients with cancer

• Impossible to follow up

Related Conditions & MeSH terms

• Cardiac Complication
• COVID-19
• Covid19
• Pneumonia

Intervention

Diagnostic Test:
• Evaluation of clinical, instrumental and laboratory diagnostics tests
During follow-up visits patients undergo clinical, instrumental and laboratory diagnostics tests

Locations

Country	Name	City	State
Russian Federation	Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science	Tyumen

Sponsors (1)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Echocardiographic assessment of cardiac function	Echocardiographic assessment of global strain parameters at 3 and 12 months after discharge	up to one year
Secondary	?????	Major adverse cardiac and cerebrovascular events: cardiac death, myocardial infarction, or stroke at 3 and 12 months after discharge	up to one year
Secondary	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	up to one year
Secondary	Functional exercises capacity assessment	Six-min walk test at 3 and 12 months after discharge	up to one year
Secondary	Evaluation of renal function	Measure of creatinine clearance at 3 and 12 months after discharge	up to one year
Secondary	Evaluation of inflammation	Analysis for C-reactive protein at 3 and 12 months after discharge	up to one year
Secondary	Evaluation of coagulation abnormality	Analysis for activated clotting time at 3 and 12 months	up to one year
Secondary	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	up to one year