Mechanical Complications of Acute Myocardial Infarction: a Multicenter Prospective Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMaastricht University Medical Center

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Surgical treatment

    Procedure/Surgery

    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)

  • Percutaneous treatment

    Procedure/Surgery

    Percutaneous 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

800 Participants
are divided into 1 treatment group
Group A: Patients with post-infarction mechanical complications2 interventions

Trial outcomes

Primary outcomes

1

In-hospital mortality

Mortality during the hospitalization for the management of post-infarction mechanical complication

Time frame
from enrollment to the end of hospitalization (up to 30 days)

Secondary outcomes

1

Long-term survival

Survival at 5 years from the diagnosis of post-infarction mechanical complication

Time frame
from enrollment to the end of follow-up (5 years from diagnosis)

Other outcomes

Sponsors and contacts

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