Other Clinical Trial - Characterization of Patients With Post-ischemic

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Left Ventricular Diastolic Dysfunction
Ventricular Dysfunction
Ventricular Dysfunction, Left

Clinical Trial Details

NCT number	NCT04699565
Study type	Observational
Source	IRCCS San Raffaele
Contact
Status	Completed
Phase
Start date	November 18, 2018
Completion date	April 30, 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Characterization of Patients With Post-ischemic Left Ventricular Dysfunction

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms