The Global PCHF-COVICAV Registry

Study Overview
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Brief Summary
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Background: Coronavirus disease (COVID-19) is a tremendous challenge the modern world has never seen before and is overwhelming the capacities of healthcare systems worldwide. Patients with cardiovascular diseases, heart failure in particular, and cardiovascular risk factors seem to be at a very high risk if affected by COVID-19 - and vice versa there are more and more reports of cardiac manifestations with the viral disease. Aim: The purpose of the study is to characterise the clinical course of adult inpatients with COVID-19 and concomitant cardiovascular affection in a worldwide, multicentre PCHF registry. Methods: Retrospective and prospective data analysis. Data on demographic, clinical, selected laboratory, electrocardiography and echocardiography parameters, treatment and outcome will be collected. The principal investigator provides dedicated electronic case report form. The primary outcome is in-hospital mortality. The secondary endpoints will be ICU length of stay, hospital length of stay, the need and duration of invasive mechanical ventilation, cardiovascular hospitalisation after 3 and 6 months from index hospitalisation, all-cause and cardiovascular mortality after 3 and 6 months from index hospitalisation.

Official Title
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COVID-19 in Hospitalised Patients With Preexisting CArdioVascular Diseases and/or Cardiac Involvement and/or Cardiovascular Risk Factors: the Global PCHF-COVICAV Registry

Conditions
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COVID-19, Cardiovascular Diseases, Cardiovascular Risk Factor, Heart Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult inpatients (≥18 years old) with laboratory-confirmed COVID-19. Exclusion Criteria: Age <18 years old. Outpatients.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CV involvement<br>Patients with COVID-19 and preexisting cardiovascular diseases and/or cardiovascular risk factors (diabetes mellitus, arterial hypertension and/or dyslipidaemia). | |
| Control<br>Patients with COVID-19 without preexisting cardiac involvement. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality. | All-cause and cardiovascular mortality during index hospitalization. | Hospitalization period, assessed up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The length of stay in the intensive care unit. | The duration of hospitalization on the intensive care unit. | Hospitalization period in the ICU, assessed up to 30 days | 
| The duration of hospitalization. | The total length of stay in the hospital. | Hospitalization period, assessed up to 30 days | 
| The need and duration of invasive mechanical ventilation. |  | Hospitalization period, assessed up to 30 days | 
| Hospitalization for cardiovascular causes or cardiovascular deaths within 3 months after hospitalization. |  | 3 months | 
| Hospitalization for cardiovascular causes or cardiovascular deaths within 6 months after hospitalization. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Cardiovascular Diseases, Cardiovascular Risk Factor, Heart Failure