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OpenTrials
Recruiting

NCT Number: NCT06801743

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospital-Universitaire d'Amiens

Salouël, 80480, France

Location status: Recruiting

Location contact

Emmanuelle VERMES, MD

CONTACT

[email protected]

33 + 0322087302

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Number of myocardial abnormalities identified by CMR

    Time frame: 1 day

    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

Secondary outcomes

  1. number of criteria to predict myocardial abnormalities on CMR

    Time frame: day 1

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuelle VERMES, MD

CONTACT

[email protected]

33 + 322087302

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: IRMESV

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 30, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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