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Hospitalizations During Pandemia in the Italian Coronary Care Unit Network (BLITZ-COVID19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04744415
Recruitment Status : Completed
First Posted : February 9, 2021
Last Update Posted : August 27, 2021
Sponsor:
Information provided by (Responsible Party):
Heart Care Foundation

Study Description
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Brief Summary:

Multicentre, national, observational, retrospective and prospective study.

The BLITZ-COVID19 study aims at describing the epidemiology of admissions to Italian Cardiology Intensive Care Units in the COVID-19 infection pandemia, the main aspects of the clinical management of inpatients, their short-term outcome, the absorption of resources related to their admission.


Condition or disease Intervention/treatment
Management and Epidemiology of Patients Admitted in ICU Other: Epidemiology of admissions

Detailed Description:

The BLITZ-COVID19 study, aims at describing the epidemiology of admissions to Italian Cardiology Intensive Care Units .

The study is observational, multicentre, national and involves the collection of clinical data, both retrospectively and prospectively, using a web-based system. In conducting the study, no drugs are tested, nor are diagnostic tests or non-pharmacological therapies performed other than those that each participating cardiologist decides to perform following the rules of normal clinical practice. Diagnostic procedures and pharmacological and non-pharmacological therapies habitually prescribed for cardiovascular pathologies, which are the object of hospitalization, and those used in the event of a COVID-19 infection, will be recorded in the database.

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 6054 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 1 Day
Official Title: Epidemiology of the Hospitalizations in the Italian Coronary Care Unit Network at the Time of Covid19
Actual Study Start Date : November 9, 2020
Actual Primary Completion Date : February 9, 2021
Actual Study Completion Date : March 23, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Epidemiology of admissions
    Cardiology Intensive Care Unit admission

Outcome Measures
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Primary Outcome Measures :
  1. Impact that COVID-19 infection may have had on the in-hospital mortality [ Time Frame: Enrollment ]
    Impact that COVID-19 infection may have had on the in-hospital mortality of the various clinical conditions admitted to ICU

  2. Epidemiology and management of patients admitted to ICU [ Time Frame: Enrollment ]
    The different diagnoses of discharge from the ICU and their frequency will be described. All hospitalized cardiac and non-cardiac pathologies will be listed, with particular reference to any COVID-19 infection.

  3. Management of patients admitted to ICU [ Time Frame: Enrollment ]
    Description of the main therapeutic decision in patients hospitalized for the most relevant pathologies


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients aged ≥18 years admitted with any diagnoses to ICU in the specified periods of 30 days each.

Retrospecitve phase:(March 1-30, 2020 in the Northern or Centre-North regions; March 15-April 13, 2020 in the Southern or Ventre_South Regions and island.

Perspective phase (depending by the IRB approval) in the following periods:

November 9-December 8, 2020; November 23-December 22, 2020; January 11-February 9, 2021.

(Retrospective study) or in the

Criteria

Inclusion Criteria:

- All patients aged ≥18 years admitted with any diagnosis to one of the participating ICU

Exclusion Criteria:

- Refuse to signe consent

Contacts and Locations
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Information from the National Library of Medicine

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): NCT04744415


Locations
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Sponsors and Collaborators
Heart Care Foundation
Investigators
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Study Chair: Michele M Gulizia, MD Heart Care Foundation
More Information
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Responsible Party: Heart Care Foundation
ClinicalTrials.gov Identifier: NCT04744415    
Other Study ID Numbers: K22
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: August 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Still to be decided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No