Impact of COVID19 Outbreak in Cardiac Acute Care

NCT04344912 | Recruiting

• 2 other identifiers: APHP2005240522070420
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Coronary Syndrome; Heart Failure; COVID

Keywords

COVID19; Acute Coronary Syndrome; Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Incidence of recurrent Major Cardiovascular Events (MACE) and urgent rehospitalization

  From admission to one year follow up

Study Arms (2)

COVID19- Population

Patients without diagnosis of COVID19, as assessed by RT-PCR and CT scan

Other: Data collection

COVID19+ Population

Patients with a diagnosis of COVID19, as assessed by RT-PCR and CT scan

Other: Data collection

Interventions

Data collection OTHER

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; COVID19- Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients treated in the CCU at Cardiology Institute of the Pitié-Salpêtrière Hospital, from Friday, March 20, 2020

You may qualify if:

• 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

You may not qualify if:

• Minor patient
• Patient who expressed opposition to participation in the study

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Action, France: collaborator

Study Sites (1)

Unité de Soins Intensifs de Cardiologie, Pitié Salpêtrière Hospital, AP-HP

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Heart Failure; COVID-19; Myocardial Infarction

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Johanne SILVAIN, MD PhD

  Sorbonne University, ACTION Group, AP-HP Pitié-Salpêtrière Hospital Paris France

  STUDY DIRECTOR

• Gilles MONTALESCOT, MD PhD

  Sorbonne University, ACTION Group, AP-HP Pitié-Salpêtrière Hospital Paris France

  STUDY CHAIR

Central Study Contacts

Johanne SILVAIN, MD PhD

CONTACT

+33142162961; johanne.silvain@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 14, 2020
• Study Start: March 20, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be available 12 months after the beginning of the Registry
• Access Criteria: to be determined

Locations

FR (1)