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Active, not recruitingNCT06146556Updated Jan 31, 2025

Concealed Myocardial Abnormalities by Cardiac Magnetic Resonance Imaging in Idiopathic VT

An observational study in Premature Ventricular Contractions, sponsored by Assiut University. Active, not recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2025-01-31.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Sex
All
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Study summary

Idiopathic Ventricular arrhythmia (VAs) refers to VAs that occur in the absence of clinically apparent structural heart disease. The outflow tracts (OTs) are the most common origin of idiopathic VAs and PVCs, accounting for approximately 10% of all patients referred for evaluation of VAs with the RVOT being the origin of about 70-80% of these arrhythmias.

Studies have shown that increased PVC burden was associated with reduced LV function, a higher incidence of heart failure, and a higher risk of death.

The diagnosis, prognostication and treatment of patients with VAs are challenging. A routine diagnostic workup that includes transthoracic echocardiography and an assessment for the presence of coronary artery disease (CAD) as recommended by current clinical guidelines cannot recognize focal structural abnormalities or underlying structural heart disease (SHD) in a substantial proportion of patients. Cardiac magnetic resonance (CMR) provides an excellent assessment of cardiac morphology and function and enables a detailed myocardial tissue characterization with a high degree of precision. CMR is widely regarded as the gold standard for identifying structural arrhythmogenic substrates in patients with VAs and normal echocardiography.

Read the detailed description

Idiopathic Ventricular arrhythmia (VAs) refers to VAs that occur in the absence of clinically apparent structural heart disease. The outflow tracts (OTs) are the most common origin of idiopathic VT and PVCs, accounting for approximately 10% of all patients referred for evaluation of VT with the RVOT being the origin of about 70-80% of these arrhythmias.

Studies have shown that increased PVC burden was associated with reduced LV function, a higher incidence of heart failure, and a higher risk of death.

The diagnosis, prognostication and treatment of patients with VAs are challenging. A routine diagnostic workup that includes transthoracic echocardiography and an assessment for the presence of coronary artery disease (CAD) as recommended by current clinical guidelines cannot recognize focal structural abnormalities or underlying structural heart disease (SHD) in a substantial proportion of patients. Cardiac magnetic resonance (CMR) provides an excellent assessment of cardiac morphology and function and enables a detailed myocardial tissue characterization with a high degree of precision. CMR is widely regarded as the gold standard for identifying structural arrhythmogenic substrates in patients with VAs and normal echocardiography. More importantly, myocardial structural abnormalities detected on CMR in patients with idiopathic VAs are associated with an increased risk of arrhythmic events and worse clinical outcomes.

However, little is known regarding the added value of CMR including feature-tracking strain CMR (FT-CMR) in identifying underlying myocardial abnormalities and biventricular dysfunction in a relatively 'healthy' population of patients with VAs and normal echocardiography.

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Conditions studied

  • Premature Ventricular Contractions

Keywords

  • idiopathic VAs
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In context

Ventricular Premature Complexes

102 studies on the registry are indexed under Ventricular Premature Complexes; 32 are open to participants now.

This study's planned enrollment of 60 is below the median of 125 across 39 observational studies indexed under Ventricular Premature Complexes.

Browse Ventricular Premature Complexes studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

All patients presented with idiopathic ventricular arrhythmias with normal diagnostic routine workup at Assiut university heart hospital.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients presented with idiopathic ventricular arrhythmias with normal diagnostic routine workup at Assiut university heart hospital. Diagnostic work up including a normal with no changes suggestive of structural heart disease, normal echocardiography findings and no evidence of CAD on either invasive or non-invasive imaging

Exclusion criteria

Exclusion Criteria:

  • (1) known history of cardiac disease (CAD, cardiomyopathy, congenital heart disease, more than mild valvular disease, previous cardiac surgery of any type), any severe systemic disease with cardiac involvement.

    (2) Allergy to gadolinium-based contrast agents, an estimated glomerular filtration rate \< 30 mL/min/1.73 m2.

    (3) Any to the MR environment (e.g., MR-unsafe implants/devices, shrapnel injury), pregnancy and claustrophobia

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Interventions

  • Procedurecatheter based ablation

    electrophysiological catheter based ablation of ventricular arrhythmia

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What researchers measure

Primary outcomes

  1. Assess the diagnostic yield of cardiac MRI in early detection of biventricular dysfunction in patients with idiopathic VAs

    the value of CMR in evaluation of ventricular dysfunction in patients with ventricular arrhythmias

    Time frame: one year

Secondary outcomes

  1. Assess the clinical predictors of myocardial dysfunction

    different risk factors for ventricular dysfunction including demographic data, clinical data as regards age, diabetus mellitus, hypertension, family history

    Time frame: one year

  2. Assess the PVCs burden association with myocardial abnormalities

    Premature ventricular ectopics burden associated with myocardial abnormalities as detected by ECG Holter monitoring as regard frequency of ectopics

    Time frame: one year

  3. Assess the PVCs morphology association with myocardial abnormalities

    assess PVCs morphology in holter monitoring as left or right bundle branch block morphology and axis

    Time frame: one year

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Study locations

1 site
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References and documents

Publications

  • 1.Aliot EM, Stevenson WG, Almendral-Garrote JM, Bogun F, Calkins CH, Delacretaz E, et al. EHRA/HRS expert consensus on catheter ablation of ventricular arrhythmias. Vol. 11, Europace. 2009. p. 771-817 2.Kim YH, Chen SA, Ernst S, Guzman CE, Han S, Kalarus Z, et al. 2019 APHRS expert consensus statement on three-dimensional mapping systems for tachycardia developed in collaboration with HRS, EHRA, and LAHRS. Vol. 36, Journal of Arrhythmia. Wiley-Blackwell; 2020. p. 215-70. 3..Pedersen CT, Kay GN, Kalman J, Borggrefe M, Della-Bella P, Dickfeld T, et al. EHRA/HRS/APHRS expert consensus on ventricular arrhythmias. EP Europace 2014 Sep 1. Available from: https://dx.doi.org/10.1093/europace/euu194 4.Andreini D, Dello Russo A, Pontone G, Mushtaq S, Conte E, Perchinunno M, et al. CMR for Identifying the Substrate of Ventricular Arrhythmia in Patients With Normal Echocardiography. Cardiovascular Imaging . 2020 Feb 1 https://www.jacc.org/doi/10.1016/j.jcmg.2019.04.023 5.Muser D, Santangeli P, Castro SA, Casado Arroyo R, Maeda S, Benhayon DA, et al. Risk Stratification of Patients With Apparently Idiopathic Premature Ventricular Contractions: A Multicenter International CMR Registry. JACC Clin Electrophysiol. 2020 Jun 1;6(6):722-35
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06146556
Lead sponsor
Assiut University
Responsible party
Eman Abdallah Hasaballah Farag (Assistant lecturer, Assiut University) — Principal investigator
First posted
Nov 24, 2023
Start date
Jan 1, 2024
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jan 31, 2025

Study contacts

shimaa sayed, MD
principal investigator · Lecturer of cardiovascular medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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