- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06146556
Concealed Myocardial Abnormalities by Cardiac Magnetic Resonance Imaging in Idiopathic VT
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Assiut, Egypt
- Assiut University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 ECG 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:
(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 contraindication to the MR environment (e.g., MR-unsafe implants/devices, shrapnel injury), pregnancy and claustrophobia
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess the clinical predictors of myocardial dysfunction
Time Frame: one year
|
different risk factors for ventricular dysfunction including demographic data, clinical data as regards age, diabetus mellitus, hypertension, family history
|
one year
|
|
Assess the PVCs burden association with myocardial abnormalities
Time Frame: one year
|
Premature ventricular ectopics burden associated with myocardial abnormalities as detected by ECG Holter monitoring as regard frequency of ectopics
|
one year
|
|
Assess the PVCs morphology association with myocardial abnormalities
Time Frame: one year
|
assess PVCs morphology in holter monitoring as left or right bundle branch block morphology and axis
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: shimaa sayed, MD, Lecturer of cardiovascular medicine
Publications and helpful links
General 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Idiopathic VT imaging
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Premature Ventricular Contractions
-
Hunter Holmes Mcguire Veteran Affairs Medical CenterWashington University School of Medicine; National Heart, Lung, and Blood Institute... and other collaboratorsActive, not recruitingCardiomyopathies | Ventricular Premature Beats, Contractions, or SystolesUnited States, Canada
-
Shanghai MicroPort EP MedTech Co., Ltd.Enrolling by invitationVentricular Tachycardia | Premature Ventricular ContractionsChina
-
Insel Gruppe AG, University Hospital BernUniversity of BernRecruitingVentricular Tachycardia | Ventricular Arrhythmia | Premature Ventricular Contractions | Ablation of ArrhythmiasSwitzerland
-
University of California, San FranciscoCompletedPremature Atrial Contractions | Premature Ventricular ContractionsUnited States
-
Catheter Precision. Inc.CompletedVentricular Tachycardia | Ventricular Arrythmia | Premature Ventricular ContractionUnited Kingdom, Netherlands, Ireland, Italy, Portugal
-
StereotaxisCompletedVentricular Tachycardia | Premature Ventricular ContractionNetherlands, Czechia
-
Mayo ClinicWithdrawnVentricular Tachycardia | Premature Ventricular ContractionUnited States
-
Catheter Precision. Inc.Completed
-
Field MedicalCompletedVentricular Tachycardia | Ventricular Arrythmia | Ventricular Tachyarrhythmia | PVC - Premature Ventricular Complex | PVC - Premature Ventricular ContractionCzechia
-
C. R. BardTerminatedBundle-Branch Block | Tachycardia | Atrioventricular Block | Atrial Flutter | Premature Ventricular Contraction | Premature Atrial Contraction | Indication for Peripheral Intravenous Catheterization | Premature Junctional ContractionUnited States, Australia
Clinical Trials on catheter based ablation
-
Erasmus Medical CenterUnknownTachycardia, Supraventricular | Tachycardia; Paroxysmal, SupraventricularNetherlands
-
Vivek ReddyBiosense Webster, Inc.TerminatedVentricular Tachycardia | Tachycardia, Ventricular | Catheter AblationUnited States, Czechia, Italy, Brazil, Canada
-
Klinikum-FuerthKlinikum NürnbergRecruitingSurgery--Complications | Anesthesia Complication | Cardiac Pacemaker Malfunction | ICD Malfunction | Cardiac Pacemaker Electrical InterferenceGermany
-
Cibiem, Inc.UnknownHypertension,EssentialAustralia, Czechia, Germany
-
University of RochesterRecruiting
-
Tsiachris DimitriosMedtronic Atrial Fibrillation SolutionsCompletedAtrial Fibrillation (AF) | Catheter Ablation | Pulmonary Vein IsolationGreece
-
Charles University, Czech RepublicRecruitingAtrial FibrillationCzechia
-
Yonsei UniversityRecruitingAtrial FibrillationKorea, Republic of
-
University Hospital, Basel, SwitzerlandRecruitingCatheter-based Ablation of Atrial FibrillationSwitzerland
-
Vivek ReddyCompletedVentricular TachycardiaUnited States, Czechia