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

NCT06801743 | Recruiting

• 1 other identifier: PI2023_843_0169
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premature Ventricular Complexes; Ventricular Arythmias; Cardiac Magnetic Resonance Imaging; Focal or Diffuse Fibrosis; Structural Heart Disease; Idiopathic

Keywords

premature ventricular complexes; ventricular arythmias; cardiac magnetic resonance; focal or diffuse fibrosis; structural heart disease; idiopathic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• number of criteria to predict myocardial abnormalities on CMR

  day 1

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

Centre Hospital-Universitaire d'Amiens

Salouël, 80480, France

RECRUITING

MeSH Terms

Conditions

Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Emmanuelle VERMES, MD

CONTACT

33 + 322087302; vermes.emmanuelle@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: November 27, 2024
• Primary Completion: November 1, 2025
• Study Completion: May 1, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)