National Registry of Cardiovascular Surgery in Argentine | NCT05199116

Studies
National Registry of Cardiovascular Surgery in Argentine

NCT05199116

Sponsor

Sociedad Argentina de Cardiología

Status

Unknown status

Last Update Posted

Jan 20, 2022Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Cardiovascular Diseases
Surgery

Interventions

Not provided

Countries

Argentina

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

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

Jul 8, 2021Actual

Primary Completion Date

Aug 30, 2022Estimated

Completion Date

Aug 31, 2022Estimated

First Submitted Date

Nov 6, 2020

First Submission Date that Met QC Criteria

Jan 14, 2022

First Posted Date

Jan 20, 2022Actual

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

Jan 14, 2022

Last Update Posted Date

Jan 20, 2022Actual

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 National Registry of Cardiovascular Surgery in Argentina is a registry of patients undergoing cardiovascular surgery that involves the entire country with the ultimate aim of determining the results of said surgery throughout the country.

Detailed Description

It is an observational registry with selective inclusion of patients who undergo certain cardiovascular surgeries, where the pre-surgical status will be analyzed, the determinants during surgery and the postoperative evolution of said patients will be evaluated

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

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
National Registry of Cardiovascular Surgery	Evaluate results of cardiovascular surgery	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Iinclusion Criteria:

Over 18 years

Myocardial revascularization surgery

Valvular surgeries

Ascending Aortic Surgery

Type A Aortic Dissection Surgery

Combined surgery

Exclusion Criteria:

Cardiovascular surgery for congenital pathologies

Peripheral vascular surgery

Cardiovascular surgery secondary to trauma

Thoracic and abdominal aorta pathology

Other surgeries

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients older than 18 years of age who underwent CCV according to the inclusion criteria.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sociedad Argentina de Cardiología	Recruiting	Buenos Aires	Buenos Aires F.D.	1407	Argentina

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

the results of the registry will be analyzed by different researchers

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

one year

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 8, 2021	Dec 2, 2021	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided