Silesian Registry of Out-of-Hospital Cardiac Arrests | NCT03654859

Studies
Silesian Registry of Out-of-Hospital Cardiac Arrests

NCT03654859

Sponsor

Silesian Centre for Heart Diseases

Status

Unknown status

Last Update Posted

May 12, 2022Actual

Enrollment

1,560Estimated

Phase

Not provided

Conditions

Out-Of-Hospital Cardiac Arrest

Interventions

cardiopulmonary resuscitation

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Aug 28, 2018

First Submission Date that Met QC Criteria

Aug 29, 2018

First Posted Date

Aug 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2022

Last Update Posted Date

May 12, 2022Actual

Name	Class
Voivodeship Rescue Service in Katowice	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Silesian Registry of Out-of-Hospital Cardiac Arrests (SIL-OHCA) which is an initiative of the Voivodeship Rescue Service in Katowice in cooperation with the Silesian Center for Heart Diseases in Zabrze is a prospective, population-based registry of out-of-hospital cardiac arrests (OHCA). The main aim of the SIL-OHCA is to asses the frequency of OHCA in the population of Upper Silesia and analyze prognostic factors for long-term survival in patients with OHCA.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,560Estimated

Name	Type	Description	Arm Group Labels	Other Names
cardiopulmonary resuscitation	Other	no pre-specified

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause mortality		12 months

Secondary Outcomes

Measure	Description	Time Frame
30-day survival or survival to discharge		30 days
Any return of spontaneous circulation	the occurence of any return of spontaneous circulation after cardiac arrest	from OHCA until transfer to the hospital or decision to withdraw CPR (assessed up to 24 hours after OHCA)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Out-of-hospital cardiac arrest treated by emergency medical services of Voivodeship Rescue Service in Katowice.

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The area covered by the registry is a part of Silesian Voivodeship, Poland, which is the region of activity of Voivodeship Rescue Service in Katowice. There are 2,700,000 inhabitants in the area covered by the registry. All cases of out-of-hospital cardiac arrest with cardiopulmonary resuscitation started or continued by emergency medical services of Voivodeship Rescue Service in Katowice, as well as cases in which resuscitation is not attempted will be included.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Voivodeship Rescue Service		Katowice			Poland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058687	Out-of-Hospital Cardiac Arrest
D006323	Heart Arrest

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016887	Cardiopulmonary Resuscitation

Ancestor Terms

ID	Term
D012151	Resuscitation
D004638	Emergency Treatment
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided