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BLITZ Atrial Fibrillation (BLITZ-AF)

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: NCT03653598
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Heart Care Foundation

Study Description
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Brief Summary:

Management strategies for AF have made many advances over the last decade but there is still a great heterogeneity in the management of AF and it remains unclear how often clinicians adhere to current guidelines.

A survey of an updated AF management would enable a timely assessment of implementation of current International guidelines, allow monitoring of early management of AF when a patients is admitted in a Emergency Room (ER) and Cardiology Unit.


Condition or disease Intervention/treatment
Atrial Fibrillation Other: Atrial Fibrillation

Detailed Description:

Multicentre, observational study. 200 Italian Hospitals fully representing the Italian cardiology reality in terms of geographical distribution and level of hospital technology.

Data collection in ER: Data on AF and Atrial Flutter episodes in ER will be collected retrospectively by checking the records of ER without collection of any data that can allow to identify the patients. These data will be collected under the responsibility of the Cardiology Departments consecutively for 4 weeks.

Data collected in Cardiology: these data will be collected under the responsibility of the Cardiology Departments for 12 weeks consecutively.

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 4125 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: BLITZ Atrial Fibrillation
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : December 30, 2016
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
AF patients
Patients with Atrial Fibrillation
 Other: Atrial Fibrillation
Data collection on Atrial Fibrillation


Outcome Measures
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Primary Outcome Measures :
  1. Number of admissions of patients with AF [ Time Frame: Enrollemnt ]
    Number of admissions to the ER and cardiology wards of patients with AF

  2. Rate or rhythm control strategy [ Time Frame: Baselane study completion - average 1 week ]
    Percentage of patients in rate or thythm control therapy

  3. Antithrombotic strategies [ Time Frame: Baselane study completion - average 1 week ]
    Rate of use of oral antithrombotic strategies


Secondary Outcome Measures :
  1. Admission to the ER for atrial flutter [ Time Frame: Enrollment ]
    Number of admission to the ER for atrial flutter

  2. Patients regularly followed up by the cardiology centers [ Time Frame: 12 months ]
    Rate of patients regularly followed up by the cardiology centers

  3. Adherence to the 1A recommendations of current guidelines [ Time Frame: 12 months ]
    Rate of adherence to the 1A recommendations of current guidelines


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 consecutive hospitalized patients with Atrial Fibrillation
Criteria

Inclusion Criteria:

  • All patients with AF, admitted to cardiology wards for an urgent or planned hospitalization.
  • All patients admitted in a Day Hospital regimen for treatment of AF The diagnosis of AF must be confirmed by ECG.
  • Signed Patient Inform Consent.

Exclusion Criteria:

  • The qualifying episode of AF was not documented with an ECG.
  • Age <18 years.
  • Patients with AF as a complication of an acute coronary syndrome (within 1 week from symptoms onset).
  • Patients with AF associated with cardiothoracic surgery (within 1 week from surgery).
  • Concomitant participation in other studies that can modify the diagnostic and/or therapeutic treatments.
  • Patients already enrolled in BLITZ-AF
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): NCT03653598


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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Additional Information:

Publications of Results:

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Responsible Party: Heart Care Foundation
ClinicalTrials.gov Identifier: NCT03653598    
Other Study ID Numbers: K16
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heart Care Foundation:
Atrial Fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes