Premature Ventricular ComplexesIRMESVNCT06801743
WHEN DO WE HAVE to PERFORM CARDIAC MAGNETIC RESONANCE in PATIENTS REFERRED for PREMATURE VENTRICULAR COMPLEXES by THEIR CARDIOLOGISTS
An observational study of Premature Ventricular Complexes and Ventricular Arythmias, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Premature Ventricular Complexes, Ventricular Arythmias, Cardiac Magnetic Resonance Imaging
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2024to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with PVC who have performed ECG, Holter ECG and a CMR
Who may be able to join
- patients with PVC who have performed ECG, Holter ECG and a CMR
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospital-Universitaire d'Amiens
Salouël, 80480
Emmanuelle VERMES, MD, 33 + 0322087302, vermes.emmanuelle@chu-amiens.fr
About this study
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).
Read more
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
- Medical subject headings
- Ventricular Premature Complexes
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (1)
number of criteria to predict myocardial abnormalities on CMR
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start27 Nov 2024
- Primary completionNov 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ventricular ComplexesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801743
- Sponsor's protocol ID
- PI2023_843_0169
- Acronym
- IRMESV
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WHEN DO WE HAVE to PERFORM CARDIAC MAGNETIC RESONANCE in PATIENTS REFERRED for PREMATURE VENTRICULAR COMPLEXES by THEIR CARDIOLOGISTS
- ClinicalTrials.gov ID
- NCT06801743
- Acronym / sponsor ID
- IRMESV / PI2023_843_0169
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with PVC who have performed ECG, Holter ECG and a CMR
Key inclusion criteria (1 listed)
- patients with PVC who have performed ECG, Holter ECG and a CMR
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
number of criteria to predict myocardial abnormalities on CMR
Time frame: day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Premature Ventricular Complexes
Not yet recruitingObservational study
Premature Ventricular Complex and Diet Inflamatuar Index
Premature Ventricular Complexes, Diet Quality
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
Recruiting
Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation
Obstructive Sleep Apnea, Premature Ventricular Contraction (PVC)
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Recruiting
Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes
Premature Ventricular Complexes, Premature Ventricular Contraction (PVC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Ventricular Complexes and Ventricular Arythmias, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmanuelle VERMES, MD (33 + 322087302, vermes.emmanuelle@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of myocardial abnormalities identified by CMR (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.