Surgical Treatment of Postinfarction Ventricular Septal Rupture.
Daniele Ronco, Matteo Matteucci, Mariusz Kowalewski...
https://pubmed.ncbi.nlm.nih.gov/34668946Actively Recruiting
Age: 18Years +
All Genders
ID06676345
Mechanical Complications of Acute Myocardial Infarction: a Multicenter Prospective Observational Study
Led by Maastricht University Medical Center · Updated on 2025-05-11
800
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study patients who have mechanical complications following an acute myocardial infarction, also known as a heart attack. These complications include conditions like ventricular free-wall rupture, ventricular pseudo-aneurysm, acute mitral regurgitation from papillary muscle rupture, and ventricular septal rupture. The study seeks to understand the outcomes of different treatments, including surgery, percutaneous (minimally invasive) procedures, and conservative care, in current medical practice. It builds upon a previous retrospective study by collecting more accurate and focused data prospectively to better reflect contemporary treatment results. Data will be collected prospectively from January 1, 2025, to December 31, 2027, across multiple cardiac surgery and cardiology departments. The study will include all patients diagnosed with post-infarction mechanical complications regardless of the treatment assigned. Treatments being evaluated include surgical repair methods such as sutured or sutureless techniques, and percutaneous approaches like device closure for ventricular septal rupture or mitral valve repair devices. There is also monitoring of patients receiving conservative (non-surgical) treatments. Approximately 800 patients are expected to be enrolled from at least 50 centers worldwide. Participants will have their demographic and clinical information, including diagnosis, key lab tests, diagnostic procedures, treatments received, complications, and hospital outcomes recorded. Follow-up will occur annually up to five years to assess quality of life, hospital readmissions, interventions, and long-term survival. The main outcome measured is in-hospital mortality up to 30 days after enrollment. Data accuracy and analysis will be managed centrally to ensure consistency, and patients will provide informed consent before participation.
CONDITIONS
Brief Title
Mechanical Complications of Acute Myocardial Infarction: a Multicenter Prospective Study
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- All patients diagnosed with post-infarction mechanical complications, regardless of treatment assigned
You will not qualify if you...
- Patients with cardiac rupture not related to acute myocardial infarction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 30 days (hospitalization period)
Participants diagnosed with post-infarction mechanical complications undergo diagnostic procedures and clinical assessments during hospitalization.
Daily hospital visits as part of routine care
Treatment
Duration - Up to 30 days or until hospital discharge
Participants receive surgical, percutaneous, or conservative treatment for mechanical complications of acute myocardial infarction as per clinical decision.
Treatment and monitoring visits during hospitalization
Long-term Monitoring
Duration - Up to 5 years from diagnosis
Participants are followed up annually to assess quality of life, survival, and the need for new hospitalizations or re-interventions.
Annual follow-up visits or health record reviews
Trial Site Locations
Total: 1 location
1
ASST dei Sette Laghi
Varese, Italy
Actively Recruiting
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Research Team
M
Matteo Matteucci, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Long-term survival after surgical treatment for post-infarction mechanical complications: results from the Caution study.
Matteo Matteucci, Daniele Ronco, Mariusz Kowalewski...
https://pubmed.ncbi.nlm.nih.gov/38327179Surgical Treatment of Post-Infarction Left Ventricular Free-Wall Rupture: A Multicenter Study.
Matteo Matteucci, Mariusz Kowalewski, Michele De Bonis...
https://pubmed.ncbi.nlm.nih.gov/33307071