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Mechanical Complications of Acute Myocardial Infarction: a Multicenter Prospective Study

NCT06676345 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2025-05-11

No results posted yet for this study

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.

Conditions

  • Ventricular Septal Defect
  • Papillary Muscle Rupture
  • Cardiac Rupture
  • Pseudoaneurysm

Interventions

PROCEDURE

Surgical 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)

PROCEDURE

Percutaneous 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)

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2027-12-31
Completion
2032-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06676345 on ClinicalTrials.gov