NCT06676345 Mechanical Complications of Acute Myocardial Infarction: a Multicenter Prospective Study
| NCT ID | NCT06676345 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maastricht University Medical Center |
| Condition | Ventricular Septal Defect |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2025-01-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * all the patients diagnosed with post-infarction mechanical complications, independently from the treatment assigned Exclusion Criteria: * patients with cardiac rupture not acute myocardial infarction related
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06676345 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ventricular Septal Defect. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06676345 currently recruiting?
Yes, NCT06676345 is actively recruiting participants. Contact the research team at matteomatteucci87@gmail.com for enrollment information.
Where is the NCT06676345 trial being conducted?
This trial is being conducted at Varese, Italy.
Who is sponsoring the NCT06676345 clinical trial?
NCT06676345 is sponsored by Maastricht University Medical Center. The trial plans to enroll 800 participants.