Characterization of Patients With Post-ischemic Left Ventricular Dysfunction

Left Ventricular Diastolic Dysfunction Clinical Trial

Official title:

Characterization of Patients With Post-ischemic Left Ventricular Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04699565
• Other study ID #: VavirimS
• Status: Completed
• Start date: November 18, 2018
• Est. completion date: April 30, 2021

Study information

• Verified date: October 2023
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: April 30, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with STEMI (first episode) (defined according to European Society of Cardiology Guidelines 2017) with symptom onset within 12h (Class I), or >12h <48h (Class IIa), successfully treated by primary PCI.

• Patients with regional systolic dysfunction of 2 or more adjacent segments of the left ventricle, in the territory of the culprit artery, documented by echocardiogram on day 2 (Echo1) and confirmed at pre-discharge follow-up (Echo2).

Exclusion Criteria:

• Patients with documented prior myocardial infarction. In the event that cardiac MRI examination performed one month after STEMI shows areas of late enhancement even in segments of the left ventricle other than those subtended by the culprit artery, the patient will be allowed to continue the study if he or she does not have significant left ventricular dilatation and has no symptoms of heart failure;

• Patients with known cardiomyopathy;

• Patients with malignant neoplasia or systemic pathology with a "quoad vitam" prognosis of less than 1 year;

• Patients with known active infectious disease;

• Patients who are unable to express valid informed consent at the time of enrollment;

• Patients with specific contraindications to the performance of cardiac MRI, including:

Wearers of non-resonance-compatible devices; Previous surgery with placement of non-resonance-compatible vascular clips Claustrophobic patients; Patients with allergies and/or other specific contraindications to the use of paramagnetic contrast agents (gadolinium).

Related Conditions & MeSH terms

• Left Ventricular Diastolic Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS AOU San Martino	Genova
Italy	IRCCS Centro Cardiologico Monzino	Milan
Italy	IRCCS Fondazione Ca' Granda	Milan
Italy	IRCCS Istituto Auxologico Italiano	Milan
Italy	Paolo Camici	Milan
Italy	Irccs Sdn	Napoli
Italy	IRCCS Policlinico San Matteo	Pavia
Italy	IRCCS Fondazione Policlinico Gemelli	Roma
Italy	IRCCS Policlinico San Donato	San Donato Milanese
Italy	IRCCS Multimedica	Sesto San Giovanni

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse left ventricular remodeling 6 month after index event	Adverse LV remodeling, defined as =12% increase in enddiastolic LV volume 6 months after STEMI; Diagnostic accuracy of CMR performed 1 month after STEMI to predict actual LV remodeling at 6 months	Six months
Secondary	Incidence of cardiovascular adverse event 1 year after STEMI in patients with evidence of left ventricular remodeling at 6 months compared with those without remodeling	Incidence of the composite endpoint of death from cardiovascular causes, re-infarction, nonfatal stroke, new coronary revascularization interventions, development of heart failure, and new hospitalizations for cardiovascular causes 1 year after STEMI in patients with evidence of left ventricular remodeling at 6 months compared with those without remodeling.	Twelve months
Secondary	Incidence of cardiovascular adverse events 1 year after STEMI in patients stratified with respect to total left ventricular viability	Incidence of cardiovascular adverse events 1 year after STEMI in patients stratified with respect to total left ventricular viability (i.e., percent left ventricular volume free of late enhancement (the total volume of the left ventricle showing no enhancement minus the volume of left ventricular myocardium with evidence of late enhancement).	Twelve months
Secondary	Predictivity of the presence of microvascular obstruction	Predictivity of the presence of microvascular obstruction (MVO) in the infarcted area measured with CMR 1 month after STEMI on the development of LV remodeling at 6 months.	Six months
Secondary	Predictivity of circulating biomarkers measured in the acute phase on the development of left ventricular remodeling six months after STEMI	Predictivity of circulating biomarkers [NT-proBNP, troponin T (TnT), PCR], measured in the acute phase on the development of left ventricular remodeling six months after STEMI.	Six months
Secondary	Predictivity of circulating biomarkers measured in the acute phase on cardiovascular adverse events 12 months after STEMI	Predictivity of circulating biomarkers (NT-proBNP, TnT, PCR), measured in the acute phase on cardiovascular adverse events 12 months after STEMI.	Twelve months