NCT04699565

Characterization of Patients With Post-ischemic Left Ventricular Dysfunction

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 303 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is an observational, prospective, multicenter study (12 hospitals belonging to the Italian Cardiology Network) in patients with STEMI ST elevation myocardial infarction (STEMI) treated successfully with primary percutaneous coronary intervention (PCI), that will be followed for 12 month after the acute event, in order to ascertain the predictive value of myocardial viability measured with cardiac magnetic resonance (1.5 T; based on the transmural distribution of late enhancement in the infarcted segments) for the identification of left ventricular (LV) remodelling (REM) 6 months after STEMI.

Detailed description

The present study is divided into 3 appointments following the standard inpatient stay for the index event (STEMI). T0: Inpatient stay for index STEMI. Assessment of eligibility for participation in the study: * STEMI diagnosis * Primary PCI * Confirmation at second-day transthoracic echocardiogram and pre-discharge echocardiogram of left ventricular dysfunction * Biomarker assay Visit 1 (V1): between 30 and 40 days post-STEMI. Clinical evaluation and performance of cardiac MRI with paramagnetic contrast agent (gadolinium) for measurement of infarct territory size and myocardial viability. Visit 2 (V2): 6 months after STEMI. Clinical evaluation and second cardiac MRI, without contrast medium, for measurement of left ventricular volumes and consequently for measurement of the presence of adverse left ventricular remodeling. Visit 3 (V3): 12 months after STEMI. Clinical re-evaluation with collection of data regarding events of interest for secondary endpoint. Performance of transthoracic echocardiogram. The examinations and follow-up visits included in this study are part of clinical practice for treatment and risk assessment in patients who suffered STEMI with the exception of cardiac MRI without contrast medium at 6 months. Cardiac magnetic resonance (CMR) data (1 month and 6 months) will be centrally analyzed post hoc at the MRI center.

Conditions

• Left Ventricular Diastolic Dysfunction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cardiac magnetic resonance	Evaluate the predictive value of myocardial viability measured with cardiac magnetic resonance for the identification of LV REM 6 months after STEMI

Timeline

• Start date: 2018-11-18
• Primary completion: 2020-09-30
• Completion: 2021-04-30
• First posted: 2021-01-07
• Last updated: 2023-10-04

Locations

10 sites across 1 country: Italy