RecruitingNCT06676345

Mechanical Complications of Acute Myocardial Infarction: a Multicenter Prospective Study

Mechanical Complications of Acute Myocardial Infarction: a Multicenter Prospective Observational Study


Sponsor

Maastricht University Medical Center

Enrollment

800 participants

Start Date

Jan 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria1

  • all the patients diagnosed with post-infarction mechanical complications, independently from the treatment assigned

Exclusion Criteria1

  • patients with cardiac rupture not acute myocardial infarction related

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Interventions

PROCEDURESurgical treatment

Surgical 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)

PROCEDUREPercutaneous treatment

Percutaneous approach for the management of post-infarction mechanical complications (e.g. percutaneous closure with device for VSR, Mitraclip for PMR, PIFIT for LVFWR)


Locations(1)

ASST dei Sette Laghi

Varese, Italy

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