Registry of Acute Coronary Syndromes in the Lazio Region... | NCT01216462

Studies
Registry of Acute Coronary Syndromes in the Lazio Region of Italy

NCT01216462

Sponsor

San Filippo Neri General Hospital

Status

Unknown status

Last Update Posted

May 21, 2015Estimated

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Acute Coronary Syndromes

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

May 2015

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

Jan 2010

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Oct 6, 2010

First Submission Date that Met QC Criteria

Oct 6, 2010

First Posted Date

Oct 7, 2010Estimated

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 20, 2015

Last Update Posted Date

May 21, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Furio Colivicchi, Director, Division of Cardiology, San Filippo Neri General Hospital, Rome, ITALY, San Filippo Neri General HospitalPrincipal Investigator

Lead Sponsor

San Filippo Neri General HospitalOTHER

Collaborators

Name	Class
Associazione Nazionale Medici Cardiologi Ospedalieri	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 NET-SCA Registry has been designed to document and evaluate the clinical epidemiology and current management of Acute Coronary Syndromes in the Lazio Region of Italy.

Detailed Description

Lazio is a region of central Italy with a resident population of about 5,600,000. The NET-SCA Registry has been designed to document and evaluate the current presentation and clinical management of Acute Coronary Syndromes (ACS) in this specific regional area of Italy. All consecutive patients with ACS admitted to CCU of 15 hospitals of the Lazio Region will be included in the registry.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

3,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Mortality		12 months

Secondary Outcomes

Measure	Description	Time Frame
Cardiovascular Mortality		12 months
New admissions of ACS		12 months
New admissions for heart failure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

admission to CCU for ACS

Exclusion Criteria:

ACS due to major extracardiac causes (i.e. traumatic)

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

Consecutive patients with ACS admitted to CCU of 15 hospitals of the Lazio Region of Italy.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Furio Colivicchi, MD	Contact	+39.06.3306.1	2429	f.colivicchi@sanfilipponeri.roma.it
Marco Tubaro, MD	Contact	+39.06.3306.1	2467	m.tubaro@sanfilipponeri.roma.it

Overall Officials

Name	Affiliation	Role
Furio Colivicchi, MD	San Filippo Neri Hospital, Rome, Italy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ospedale "G.B. Grassi"	Recruiting	Rome	Italy	00122	Italy

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided