Study on Post-acute Myocardial Infarction Ventricular Def... | NCT06799780

Studies
Study on Post-acute Myocardial Infarction Ventricular Defect: Outcome Evalutation in Relation to Surgical Timing

NCT06799780

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Status

Recruiting

Last Update Posted

Jan 29, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Myocardial Infarction (MI)
Heart Disease

Interventions

Not provided

Countries

Italy
Spain

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

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 12, 2024Actual

Primary Completion Date

Nov 30, 2026Estimated

Completion Date

Nov 30, 2026Estimated

First Submitted Date

Nov 28, 2024

First Submission Date that Met QC Criteria

Jan 28, 2025

First Posted Date

Jan 29, 2025Actual

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 28, 2025

Last Update Posted Date

Jan 29, 2025Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The main objective of the study is to identify the optimal surgical timing for the treatment of intraventricular defects after acute myocardial infarction.

Detailed Description

Identify the optimal timing for the treatment of post-infarction ventricular defect, considering the time interval between the clinical-instrumental diagnosis and the surgical intervention.

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

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identify the optimal timing for the surgical intervention.	The optimal timing considering the time interval between the clinical-instrumental diagnosis and the surgical intervention	Possible timing for surgery can be: onset of the infarction episode, hospital admission, before seven days from the acute myocardial infarction or after seven days from the acute myocardial infarction.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients over eighteen years of age
Patients with post-myocardial infarction ventricular septal defect treated surgically
Patients who have signed the informed consent

Exclusion Criteria:

Patients with post-infarction ventricular septal defect treated with medical/conservative therapy
Patients with ventricular septal defects not due to acute myocardial infarction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients undergoing surgical repair of post-AMI ventricular septal defect between January 1, 2001 and December 31, 2021.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Luca Di Marco, MD	Contact	0512149044	+39	luca.dimarco@aosp.bo.it

Overall Officials

Name	Affiliation	Role
Luca Di Marco, MD	IRCCS Azienda Ospedaliero-Universitaria di Bologna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Azienda Ospedaliero-Universitaria di Bologna	Recruiting	Bologna	Bologna	40138	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
D009203	Myocardial Infarction
D006331	Heart Diseases

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D007238	Infarction

Browse Leaves

Not provided

Browse Branches

Not provided