Cardiac Arrest Registry of the Lombardia Region (Lombardi... | NCT03197142

Studies
Cardiac Arrest Registry of the Lombardia Region (Lombardia CARe)

NCT03197142

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Status

Unknown status

Last Update Posted

Feb 14, 2023Actual

Enrollment

15,000Estimated

Phase

Not provided

Conditions

Out-Of-Hospital Cardiac Arrest

Interventions

Not provided

Countries

Italy

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

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2014Actual

Primary Completion Date

Oct 1, 2024Estimated

Completion Date

Oct 1, 2024Estimated

First Submitted Date

Jun 17, 2017

First Submission Date that Met QC Criteria

Jun 21, 2017

First Posted Date

Jun 23, 2017Actual

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

Feb 11, 2023

Last Update Posted Date

Feb 14, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Simone Savastano, Cardiologist, Principal Investigator of Pavia CARe, Fondazione IRCCS Policlinico San Matteo di PaviaPrincipal Investigator

Lead Sponsor

Fondazione IRCCS Policlinico San Matteo di PaviaOTHER

Collaborators

Name	Class
Azienda Regionale Emergenza Urgenza - AREU Lombardia	OTHER
Azienda Socio-Sanitaria Territoriale di Pavia	UNKNOWN
Azienda Socio Sanitaria Territoriale di Lodi	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

The registry enroll all the patients who suffered an out-of-hospital cardiac arrest in the Lombardia Region with a follow-up up to ten years after the event.

Detailed Description

The registry is an observational study which enroll all the patients who suffered an out-of-hospital cardiac arrest of any etiology in the Lombardia Region The follow-up of the patients is at 1 month after the event, 6 month and every year up to five years after the event.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Out-of-hospital cardiac arrest		All the patients who suffered an out-of-hospital cardiac arrest in the Lombardia Region

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival with good neurological outcome for OHCA patients of any etiology	Survival with Cerebral Performance Category of 1 or 2	From cardiac arrest date up to 10 years or up to death, whichever come first

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Out-of-hospital cardiac arrest of any etiology in the Lombardia Region

Exclusion Criteria:

In-hospital cardiac arrest

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

All the patients who suffered an out-of-hospital cardiac arrest of any etiology in the Lombardia Region

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Simone Savastano, MD	Contact			s.savastano@smatteo.pv.it
Enrico Baldi, MD	Contact			enrico.baldi88@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azienda Socio Sanitaria Territoriale di Crema	Recruiting	Crema	Cremona	26013	Italy

IPD Sharing Statement Module

Plan to Share IPD

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