The Global PCHF-COVICAV Registry (PCHF-COVICAV)
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| ClinicalTrials.gov Identifier: NCT04390555 |
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Recruitment Status : Unknown
Verified May 2020 by University of Zurich.
Recruitment status was: Recruiting
First Posted : May 15, 2020
Last Update Posted : May 15, 2020
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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.
| Condition or disease |
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| COVID-19 Cardiovascular Diseases Cardiovascular Risk Factor Heart Failure |
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 1500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| Target Follow-Up Duration: | 6 Months |
| Official Title: | COVID-19 in Hospitalised Patients With Preexisting CArdioVascular Diseases and/or Cardiac Involvement and/or Cardiovascular Risk Factors: the Global PCHF-COVICAV Registry |
| Actual Study Start Date : | April 30, 2020 |
| Estimated Primary Completion Date : | December 2020 |
| Estimated Study Completion Date : | July 2021 |
| Group/Cohort |
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CV involvement
Patients with COVID-19 and preexisting cardiovascular diseases and/or cardiovascular risk factors (diabetes mellitus, arterial hypertension and/or dyslipidaemia).
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Control
Patients with COVID-19 without preexisting cardiac involvement.
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- In-hospital mortality. [ Time Frame: Hospitalization period, assessed up to 30 days ]All-cause and cardiovascular mortality during index hospitalization.
- The length of stay in the intensive care unit. [ Time Frame: Hospitalization period in the ICU, assessed up to 30 days ]The duration of hospitalization on the intensive care unit.
- The duration of hospitalization. [ Time Frame: Hospitalization period, assessed up to 30 days ]The total length of stay in the hospital.
- The need and duration of invasive mechanical ventilation. [ Time Frame: Hospitalization period, assessed up to 30 days ]
- Hospitalization for cardiovascular causes or cardiovascular deaths within 3 months after hospitalization. [ Time Frame: 3 months ]
- Hospitalization for cardiovascular causes or cardiovascular deaths within 6 months after hospitalization. [ Time Frame: 6 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Adult inpatients (≥18 years old) with laboratory-confirmed COVID-19.
Exclusion Criteria:
- Age <18 years old.
- Outpatients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390555
| Contact: Mateusz Sokolski, MD, PhD | +48717331112 | mateusz.sokolski@umed.wroc.pl | |
| Contact: Sander Trenson, MD | +41442554939 | sander.trenson@usz.ch |
| Switzerland | |
| Zurich Heart Center, Unispital Zurich | Recruiting |
| Zurich, Switzerland, 8006 | |
| Study Director: | Frank Ruschitzka, Prof. Dr. med | University Hospital Zurich, Zurich, Switzerland | |
| Principal Investigator: | Andreas Flammer, PD Dr. med | University Hospital Zurich, Zurich, Switzerland | |
| Principal Investigator: | Mateusz Sokolski, MD, PhD | Wroclaw Medical University, Wroclaw, Poland |
Publications:
| Responsible Party: | University of Zurich |
| ClinicalTrials.gov Identifier: | NCT04390555 |
| Other Study ID Numbers: |
PCHF-COVICAV |
| First Posted: | May 15, 2020 Key Record Dates |
| Last Update Posted: | May 15, 2020 |
| Last Verified: | May 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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COVID-19 Cardiovascular Diseases Cardiovascular Risk Factor Heart Failure |
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COVID-19 Heart Failure Cardiovascular Diseases Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Heart Diseases |