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

Study Overview
=================
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.

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

Conditions
-----------------
Covid19, Cardiac Complication

Intervention / Treatment
-----------------
* Diagnostic Test: Evaluation of clinical, instrumental and laboratory diagnostics tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients with documented COVID-19 pneumonia Exclusion Criteria: Patients with cancer Impossible to follow up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Covid19 pneumonia patients<br>The study includes men and women ≥18 years old with documented COVID-19 pneumonia | Diagnostic Test: Evaluation of clinical, instrumental and laboratory diagnostics tests<br>* During follow-up visits patients undergo clinical, instrumental and laboratory diagnostics tests<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiographic assessment of cardiac function | Echocardiographic assessment of global strain parameters at 3 and 12 months after discharge | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| МАССЕ | Major adverse cardiac and cerebrovascular events: cardiac death, myocardial infarction, or stroke at 3 and 12 months after discharge | 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 | up to one year | 
| Functional exercises capacity assessment | Six-min walk test at 3 and 12 months after discharge | up to one year | 
| Evaluation of renal function | Measure of creatinine clearance at 3 and 12 months after discharge | up to one year | 
| Evaluation of inflammation | Analysis for C-reactive protein at 3 and 12 months after discharge | up to one year | 
| Evaluation of coagulation abnormality | Analysis for activated clotting time at 3 and 12 months | 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 | up to one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid19, Cardiovascular Disease, Echocardiography