Premature Ventricular ContractionsNCT06146556
Concealed Myocardial Abnormalities by Cardiac Magnetic Resonance Imaging in Idiopathic VT
An observational study of Premature Ventricular Contractions, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Premature Ventricular Contractions
- What is being tested?
- catheter based ablation
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 31 Dec 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients presented with idiopathic ventricular arrhythmias with normal diagnostic routine workup at Assiut university heart hospital.
Who may be able to join
- All patients presented with idiopathic ventricular arrhythmias with normal diagnostic routine workup at Assiut university heart hospital. Diagnostic work up including a normal ECG with no changes suggestive of structural heart disease, normal echocardiography findings and no evidence of CAD on either invasive or non-invasive imaging
Who cannot join
- (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.
- Allergy to gadolinium-based contrast agents, an estimated glomerular filtration rate < 30 mL/min/1.73 m2.
- Any contraindication to the MR environment (e.g., MR-unsafe implants/devices, shrapnel injury), pregnancy and claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concealed Myocardial Abnormalities by Cardiac Magnetic Resonance Imaging in Idiopathic Ventricular Arrhythmias
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.
- Conditions
- Premature Ventricular Contractions
- Being tested
- catheter based ablation
- Keywords
- idiopathic VAs
- Medical subject headings
- Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheter based ablationProcedure or surgery
electrophysiological catheter based ablation of ventricular arrhythmia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (3)
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
Measured: one year
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
Measured: one year
Assess the PVCs morphology association with myocardial abnormalities
assess PVCs morphology in holter monitoring as left or right bundle branch block morphology and axis
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Jan 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature Ventricular ContractionsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Abdallah Hasaballah Farag, Assiut University
- Investigators
- shimaa sayed, MD, Principal investigator, Lecturer of cardiovascular medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146556
- Sponsor's protocol ID
- Idiopathic VT imaging
- Status last verified
- Jan 2025
- First submitted
- 22 Sep 2023
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concealed Myocardial Abnormalities by Cardiac Magnetic Resonance Imaging in Idiopathic Ventricular Arrhythmias
- ClinicalTrials.gov ID
- NCT06146556
- Acronym / sponsor ID
- Idiopathic VT imaging
- Conditions
- Premature Ventricular Contractions
- Keywords
- idiopathic VAs
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Nov 2023 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients presented with idiopathic ventricular arrhythmias with normal diagnostic routine workup at Assiut university heart hospital.
Key inclusion criteria (1 listed)
- All patients presented with idiopathic ventricular arrhythmias with normal diagnostic routine workup at Assiut university heart hospital. Diagnostic work up including a normal ECG with no changes suggestive of structural heart disease, normal echocardiography findings and no evidence of CAD on either invasive or non-invasive imaging
Key exclusion criteria (3 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| catheter based ablationelectrophysiological catheter based ablation of ventricular arrhythmia | Procedure or surgery | – |
Primary outcome
Assess the diagnostic yield of cardiac MRI in early detection of biventricular dysfunction in patients with idiopathic VAs
Time frame: one year
the value of CMR in evaluation of ventricular dysfunction in patients with ventricular arrhythmias
3 secondary outcomes
Assess the clinical predictors of myocardial dysfunction
Time frame: one year
Assess the PVCs burden association with myocardial abnormalities
Time frame: one year
Assess the PVCs morphology association with myocardial abnormalities
Time frame: one year
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 31 Jan 2025.
- Background1.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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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. This study is not recruiting at the moment.
shimaa sayed, MD principal investigator
Lecturer of cardiovascular medicine
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 Contractions, run by Assiut University at 1 site in Egypt.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 31 Jan 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 Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the diagnostic yield of cardiac MRI in early detection of biventricular dysfunction in patients with idiopathic VAs (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06146556, which also lists 1 linked publication.
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 31 Jan 2025.