CCU-COVID19: Impact of COVID19 Outbreak in Cardiac Acute Care

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04344912
• Collaborator: Action, France (Other)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 4.4
• Patients Per Site Per Month: 113.6

Study Details

Study Description

Brief Summary

This registry will evaluate the impact of the COVID19 outbreak on Cardiac patients admitted in the Intensive Care Unit of the Pitie-Salpetriere Hospital in Paris, France

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome; Heart Failure; COVID	Other: Data collection

Detailed Description

Registry on Characteristics and outcomes of Cardiac patients (COVID- and COVID+) hospitalized in the Intensive Care Unit of the Pitie-Salpetriere Hospital in Paris, France

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Impact of COVID19 Outbreak in Cardiac Patients Admitted in Intensive Care Unit : the CCU-COVID19 Study
• Actual Study Start Date: Mar 20, 2020
• Anticipated Primary Completion Date: Jun 1, 2020
• Anticipated Study Completion Date: Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
COVID19- Population Patients without diagnosis of COVID19, as assessed by RT-PCR and CT scan	Other: Data collection; Diagnostic and prognostic evaluation of cardiac patients hospitalized in CCU during the COVID-19 outbreak; patient's immune status regarding the presence of SARS-CoV-2 specific antibodies
COVID19+ Population Patients with a diagnosis of COVID19, as assessed by RT-PCR and CT scan	Other: Data collection; Diagnostic and prognostic evaluation of cardiac patients hospitalized in CCU during the COVID-19 outbreak; patient's immune status regarding the presence of SARS-CoV-2 specific antibodies

Outcome Measures

Primary Outcome Measures

1. Incidence of recurrent Major Cardiovascular Events (MACE) and urgent rehospitalization [From admission to one year follow up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years and older

• Admitted in the Cardiac Intensive Care Unit from March 20th 2020

• Patient informed and having expressed his non-opposition to participate in the research

Exclusion Criteria:

• Minor patient

• Patient who expressed opposition to participation in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Unité de Soins Intensifs de Cardiologie, Pitié Salpêtrière Hospital, AP-HP	Paris		France	75013

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris
• Action, France

Investigators

• Study Director: Johanne SILVAIN, MD PhD, Sorbonne University, ACTION Group, AP-HP Pitié-Salpêtrière Hospital Paris France
• Study Chair: Gilles MONTALESCOT, MD PhD, Sorbonne University, ACTION Group, AP-HP Pitié-Salpêtrière Hospital Paris France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT04344912
• Other Study ID Numbers: APHP200524; 0522070420
• First Posted: Apr 14, 2020
• Last Update Posted: Apr 28, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Assistance Publique - Hôpitaux de Paris: COVID19; Acute Coronary Syndrome; Myocardial Infarction
• Additional relevant MeSH terms: COVID-19; Acute Coronary Syndrome

Study Results

No Results Posted as of Apr 28, 2020