Actively Recruiting
Prospective Study on Treatments for Mechanical Complications After Acute Heart Attack Including Surgery, Percutaneous, and Conservative Care
Led by Maastricht University Medical Center · Updated on 2025-05-11
800
Participants Needed
1
Research Sites
261 weeks
Total Duration
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
Research Team
M
Matteo Matteucci, MD, PhD
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