Mechanical Complications of Acute Myocardial Infarction During COVID-19 Pandemics (CautionCov19)

Mechanical Complications of Acute Myocardial Infarction: an International Multicenter Cohort Study During COVID-19 Pandemics (CautionCov19)

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.

Study Overview

• Status: Completed
• Conditions: Ventricular Septal Rupture; Papillary Muscle Rupture; Free Wall Rupture, Heart
• Intervention / Treatment: Procedure: Surgical repair; Procedure: Percutaneous treatment; Procedure: Mitral valve surgery

Detailed Description

Mechanical complications must be carefully searched for in any patient with an acute coronary syndrome and signs of cardiogenic shock, as prompt diagnosis and immediate surgery often represent the only effective treatment for such ominous conditions.

The management of patients with postinfarction mechanical complications requires the consideration of several factors: (i) the extremely poor prognosis without surgical treatment; (ii) the higher mortality risk associated with emergency surgery; (iii) the potential rapid deterioration of initially stable patients.

Data from the Society of Thoracic Surgeons National Database demonstrated an average 43% in-hospital/30-day mortality for surgical treatment of ventricular septal rupture. Data from the same registry on papillary muscle rupture showed a 30-day mortality of 20%. Matteucci et al. recently reported a 36.4% mortality rate for free wall rupture from the large CAUTION multicenter study.

Given the low incidence of these post-AMI mechanical complications, evidence-based therapeutic strategies remain controversial, and little is known on the early clinical results and late follow-up, with most information derived from small single-center experiences or national registries.

Therefore, we started the "Mechanical complications of acute myocardial infarction: an international multicenter cohort study" - (Caution Study 1), a retrospective, international multicenter clinical trial aimed at evaluating the survival, postoperative outcome and quality of life of patients undergone cardiac surgery for post-infarction mechanical complications starting from 2001.

The ongoing COVID-19 pandemics, however, 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.This 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.

"Mechanical complications of acute myocardial infarction: an international multicenter cohort study during COVID-19 pandemics" is a retrospective, international multicenter clinical trial aimed at evaluating the trend of incidence, types of treatment and survival of patients admitted to hospital with a diagnosis of post-infarction mechanical complications.

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Matteucci Matteo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Wounds and Injuries; Heart Rupture, Post-Infarction; Myocardial Infarction; Infarction; COVID-19; Rupture; Heart Rupture; Ventricular Septal Rupture
• Other Study ID Numbers: IT-VA:85/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No