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

NCT06799780 | Recruiting

• 1 other identifier: DIV post-IMA
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 4

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.

Conditions

Myocardial Infarction (MI); Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (4)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Ospedale Santa Maria della Misericordia Udine

Udine, Udine, 33100, Italy

RECRUITING

Ospedale di Circolo e Fondazione Macchi Varese

Varese, Varese, 21010, Italy

RECRUITING

Hospital Clinic Barcellona

Barcelona, Barcellona, 08024, Spain

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction; Heart Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Luca Di Marco, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Di Marco, MD

CONTACT

0512149044; luca.dimarco@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: January 29, 2025
• Study Start: February 12, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: January 29, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); IT (3)