About this trial
In 2019, the international study titled "CAUTION Study - 1" (MeChanical complicAtions of acUte myocardial infarcTion: an InternatiOnal multiceNter cohort study), a retrospective multicenter study, was launched and registered on ClinicalTrials.gov (Identifier: NCT03848429). This study highlighted the outcomes of surgical treatment of post-infarction mechanical complications in patients operated between 2000 and 2019. Several scientific publications have resulted from this registry, which involved 27 international centers and recruited about 800 patients. However, retrospective studies are inherently limited by factors such as selection bias and a high number of missing data, affecting data interpretation and consistency of results. Moreover, most registries report only data about surgical patients or, in rare situations, about patients treated percutaneously. To overcome these limitations, a prospective study has been designed to collect more precise and focused data and achieve results that better reflect the current clinical practice, including all the patients diagnosed with post-infarction mechanical complications, independently from the treatment assigned.
"CAUTION Study - 2" is, therefore, a prospective, multicenter cohort study with the primary aim of analyzing the outcomes of surgical, percutaneous and conservative treatment of post-infarction mechanical complications in the contemporary era.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
all the patients diagnosed with post-infarction mechanical complications, independently from the treatment assigned
Disqualifiers
patients with cardiac rupture not acute myocardial infarction related
Trial population
patients diagnosed with post-infarction mechanical complications
Trial design
Cohort
Prospective
Treatments tested in this trial
Surgical treatment
Procedure/SurgerySurgical repair of post-infarction mechanical complications (e.g. sutureless or sutured repair for LVFWR, David or Daggett technique for VSR, mitral valve repair or replacement for PMR)
Percutaneous treatment
Procedure/SurgeryPercutaneous approach for the management of post-infarction mechanical complications (e.g. percutaneous closure with device for VSR, Mitraclip for PMR, PIFIT for LVFWR)
Treatment groups
Trial outcomes
Primary outcomes
In-hospital mortality
Mortality during the hospitalization for the management of post-infarction mechanical complication
Secondary outcomes
Long-term survival
Survival at 5 years from the diagnosis of post-infarction mechanical complication
Sponsors and contacts
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