Characterization of Patients With Post-ischemic Left Ventricular Dysfunction

NCT04699565 | Completed DMC

• 1 other identifier: VavirimS
• Study Type: observational
• Target: 303
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Left Ventricular Diastolic Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  Twelve months

• Incidence of cardiovascular adverse events 1 year after STEMI in patients stratified with respect to total left ventricular viability

  Twelve months

• Predictivity of the presence of microvascular obstruction

  Six months

• Predictivity of circulating biomarkers measured in the acute phase on the development of left ventricular remodeling six months after STEMI

  Six months

• Predictivity of circulating biomarkers measured in the acute phase on cardiovascular adverse events 12 months after STEMI

  Twelve months

Interventions

Cardiac magnetic resonance DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients with acute ST-segment elevation myocardial infarction (STEMI) treated with effective primary angioplasty (PCI)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (10)

IRCCS AOU San Martino

Genova, Italy

Location

IRCCS Centro Cardiologico Monzino

Milan, Italy

Location

IRCCS Fondazione Ca' Granda

Milan, Italy

Location

IRCCS Istituto Auxologico Italiano

Milan, Italy

Location

Paolo Camici

Milan, Italy

Location

Irccs Sdn

Napoli, Italy

Location

IRCCS Policlinico San Matteo

Pavia, Italy

Location

IRCCS Fondazione Policlinico Gemelli

Roma, Italy

Location

IRCCS Policlinico San Donato

San Donato Milanese, Italy

Location

IRCCS Multimedica

Sesto San Giovanni, Italy

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• Paolo Camici, MD, FACC

  Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Paolo G. Camici MD, FACC

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 7, 2021
• Study Start: November 18, 2018
• Primary Completion: September 30, 2020
• Study Completion: April 30, 2021
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (10)