Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04813692 |
| Other study ID # |
IT-VA:85/2021 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
July 31, 2022 |
Study information
| Verified date |
June 2023 |
| Source |
Maastricht University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
