Mechanical Complications of Acute Myocardial Infarction During COVID-19 Pandemics

NCT04813692 | Completed

• 1 other identifier: IT-VA:85/2021
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The ongoing COVID-19 pandemics has put an overwhelming pressure on the healthcare systems of many European countries. Such a situation has potentially led to delayed and impaired access to appropriate treatment for patients affected by other severe, non-COVID-19-related conditions, including cardiovascular diseases. This resulted in a reported lower admission, but higher mortality rate for AMI patients. Such a situation might be explained by many factors, including unavailability of early reperfusion therapy and late hospital presentation of AMI patients due to a general anxiety related to the COVID-19 contagious risk of the hospital environment. As a matter of fact, during this year of pandemics, several case reports suggested a new, significant surge of post-AMI mechanical complications, sometimes describing patients admitted in too severe conditions to consider surgical repair a viable option, and therefore inevitably undergone an unfavorable outcome. Therefore, we decided to involve the large network of European centers already participating to the "Caution Study 1", in order to study the impact of COVID-19 pandemics on the outcomes, incidence and treatments of post-AMI mechanical complications.

Conditions

Ventricular Septal Rupture; Papillary Muscle Rupture; Free Wall Rupture, Heart

Outcome Measures

Primary Outcomes (1)

• In-hospital survival

  To assess the in-hospital survival rate of patients admitted with a diagnosis of post-AMI mechanical complications and underwent surgical or percutaneous treatment

  interval from intervention (surgical or percutaneous) to hospital discharge (expected: up to 4 weeks)

Interventions

Surgical repair PROCEDURE

Surgical repair of post-infarction LVFWR or VSR

Percutaneous treatment PROCEDURE

Percutaneous closure of post-infarction VSR (or treatment for LVFWR)

Mitral valve surgery PROCEDURE

Mitral valve repair or replacement for post-infarction PMR

Eligibility Criteria

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

Study Population

All adult patients who were diagnosed with mechanical complications of acute myocardial infarction, between March 2018 to February 2021, independent of the treatment offered.

You may qualify if:

• patients ≥ 18 years old;
• recent diagnosis of acute myocardial infarction;
• presence of ventricular free-wall rupture and/or ventricular septal rupture and/or papillary muscle rupture.

You may not qualify if:

• patients \< 18 years old;
• ventricular free-wall rupture or ventricular septal rupture or papillary muscle rupture not related with acute myocardial infarction.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Matteucci Matteo

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Ventricular Septal Rupture; Heart Rupture

Interventions

Wound Healing

Condition Hierarchy (Ancestors)

Heart Rupture, Post-Infarction; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena

Study Design

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

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 24, 2021
• Study Start: March 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: July 31, 2022
• Last Updated: June 12, 2023

Record last verified: 2023-06

Locations

NL (1)