WHEN DO WE HAVE to PERFORM CARDIAC MAGNETIC RESONANCE in PATIENTS REFERRED for PREMATURE VENTRICULAR COMPLEXES by THEIR CARDIOLOGISTS (IRMESV)

Premature ventricular complexes (PVC) are a common entity affecting approximatively 20% of the general population. It can be discovered incidentally on electrocardiogram (ECG) or associated with symptoms with a wide spectrum from palpitations, chest pain, to syncope.

The initial and non invasive assessment includes holter ECG monitoring, a transthoracic echocardiography (TTE) and an exercise stress test to rule out structural heart disease (SHD), and referred to as benign or "idiopathic" ventricular arrhythmias (IVA).

However, these exams may fail to identify subtle myocardial abnormalities such as arrhythmogenic right ventricle dysplasia (ARVD), apical hypertrophic cardiomyopathy, healed myocarditis, ischemic or non-ischemic cardiomyopathies.

Cardiac magnetic resonance (CMR) imaging is the gold standard modality to assess regional and global ventricular function. It is also a unique modality to non-invasively detect myocardial edema, myocardial fatty replacement, focal and diffuse fibrosis and could potentially identify SHD in patients with PVC.

However, the role of CMR is uncertain, recommended in case of atypical presentation or when the initial assessment can't exclude a cardiomyopathy (recommendations class IIa).

This study sought to determine whether and when CMR can be performed to provide diagnosis or prognostic information complementary to initial assessment in patients referred for PVC by their cardiologists.

Study Overview

• Status: Recruiting
• Conditions: Structural Heart Disease; Cardiac Magnetic Resonance Imaging; Premature Ventricular Complexes; Ventricular Arythmias; Focal or Diffuse Fibrosis; Idiopathic

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Emmanuelle VERMES, MD; Phone Number: 33 + 322087302; Email: vermes.emmanuelle@chu-amiens.fr

Study Locations

• France
  • Salouel, France, 80480
    • Recruiting
    • Centre Hospital-Universitaire d'Amiens
    • Contact: Emmanuelle VERMES, MD; Phone Number: 33 + 0322087302; Email: vermes.emmanuelle@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with PVC who have performed ECG, Holter ECG and a CMR

Description

Inclusion Criteria:

• patients with PVC who have performed ECG, Holter ECG and a CMR

Exclusion Criteria:

• patient showing opposition tu use his personal data for the reseach,
• patient unable to express his opposition,
• patient deprived of liberty,
• patient with language issues (speaking or writing French)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of myocardial abnormalities identified by CMR	Composite endpoint of myocardial abnormalities identified by CMR including dilated cardiomyopathy, hypertrophic cardiomyopathy, ischemic cardiomyopathy, ventricular non-compaction, ARVD, myocarditis, pericarditis, sarcoidosis, amyloidosis, Fabry disease	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
number of criteria to predict myocardial abnormalities on CMR	day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: January 24, 2025
• First Submitted That Met QC Criteria: January 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: cardiac magnetic resonance; idiopathic; premature ventricular complexes; structural heart disease; ventricular arythmias; focal or diffuse fibrosis
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Urogenital Diseases; Cardiovascular Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Arrhythmias, Cardiac; Cardiac Complexes, Premature; Premature Birth; Heart Diseases; Fibrosis; Ventricular Premature Complexes
• Other Study ID Numbers: PI2023_843_0169

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No