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- Essai clinique NCT01250912
Imaging With a Radio Tracer to Guide VT Ablations
Three Dimension Neuron Imaging Using 123I-metaiodobenzylguanidine Single Photon Emission Computed Tomography to Guide Ventricular Tachycardia Ablations
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Ventricular tachycardia is the next frontier in cardiology. Patients that have scar in the heart (for example after heart attacks) are at an increased risk of developing ventricular tachycardia. In these patients ventricular tachycardia represents an electrical wave front that circulates in the heart muscle using the scar in the heart. An increasing number of patients with ventricular tachycardia require cauterization (burning away) of the tissue to treat this life-threatening condition. The goal of this cauterization or ablation is to destroy "highways of surviving tissue" inside the scar, that allow ventricular tachycardia to exist. However, this can be very lengthy procedure (>5 hours) that has only a moderate success in the long run. Therefore, new treatment approaches are needed to make this procedure better.
The purpose of this study is to assess if radio tracers showing the nerve distribution in the heart (cardiac innervation) can be used in addition to the current technology ("voltage mapping") to identify the area that needs to be ablated (burnt away) to treat life-threatening fast heart rates (ventricular tachycardia)
Certain patterns of nerve distribution in the heart (sympathetic cardiac innervation) have been shown to predict outcome for different heart diseases, like heart transplant, coronary artery disease, heart failure, arrhythmias. One substance that allows visualization of the cardiac innervation is 123I-metaiodobenzylguanidine (123I-MIBG), which could provide additional information to understand and treat ventricular tachycardia.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Maryland
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Baltimore, Maryland, États-Unis, 21201
- University of Maryland Medical Center, EP Lab, Rm. N3W77
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients with ventricular arrhythmias requiring VT Ablation
- Patients must be 18 years of age or older
- Patient must be able to sign consent form
- Patient must be willing to come back for the 6 month visit for additional study procedures
Exclusion Criteria:
- Patient under 18 years old
- Inability to sign consent
- Pregnant Women
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Imaging Tracer
No arms, the Radio tracer will be used in all subjects imaging tests.
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FDA Approved for use in Cancer patients.
This use is Off Label.
For the imaging study, an activity of 370 MBq (10 mCi) 123I-mIBG (GE Healthcare) will be administered intravenously, and a 10-minute planar image of the anterior thorax (128_128 matrix) will be acquired beginning 15 minutes after tracer injection.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline
Délai: Baseline
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Scar Measurement on both MIBG 3D map and electroanatomic scare defined as bipolar voltage <0.5mV using Standard 17-segment American Heart Association areas.
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Baseline
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Median Segmental MIBG Uptake at Baseline
Délai: Baseline
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The median uptake of the standard 17 heart segments was determined at baseline
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Baseline
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Median Segmental MIBG Uptake at 6 Months After Ablation
Délai: 6 months after ablation
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MIBG/SPECT imaging 6 months after ablation.
123I-metaiodobenzylguanidine: For the imaging study, an activity of 370 MBq (10 mCi) 123I-mIBG (GE Healthcare) was administered intravenously, and a 10-minute planar image of the anterior thorax (128_128 matrix) was acquired beginning 15 minutes after tracer injection.
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6 months after ablation
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Timm R Dickfeld, MD,Ph.D, University of Maryland Medical Center
Publications et liens utiles
Publications générales
- Tian J, Smith MF, Jeudy J, Dickfeld T. Multimodality fusion imaging using delayed-enhanced cardiac magnetic resonance imaging, computed tomography, positron emission tomography, and real-time intracardiac echocardiography to guide ventricular tachycardia ablation in implantable cardioverter-defibrillator patients. Heart Rhythm. 2009 Jun;6(6):825-8. doi: 10.1016/j.hrthm.2009.02.032. Epub 2009 Feb 24. No abstract available.
- Tian J, Smith MF, Chinnadurai P, Dilsizian V, Turgeman A, Abbo A, Gajera K, Xu C, Plotnick D, Peters R, Saba M, Shorofsky S, Dickfeld T. Clinical application of PET/CT fusion imaging for three-dimensional myocardial scar and left ventricular anatomy during ventricular tachycardia ablation. J Cardiovasc Electrophysiol. 2009 Jun;20(6):567-604. doi: 10.1111/j.1540-8167.2008.01377.x.
- Dickfeld T, Kocher C. The role of integrated PET-CT scar maps for guiding ventricular tachycardia ablations. Curr Cardiol Rep. 2008 Mar;10(2):149-57. doi: 10.1007/s11886-008-0025-1.
- Klein T, Abdulghani M, Smith M, Huang R, Asoglu R, Remo BF, Turgeman A, Mesubi O, Sidhu S, Synowski S, Saliaris A, See V, Shorofsky S, Chen W, Dilsizian V, Dickfeld T. Three-dimensional 123I-meta-iodobenzylguanidine cardiac innervation maps to assess substrate and successful ablation sites for ventricular tachycardia: feasibility study for a novel paradigm of innervation imaging. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):583-91. doi: 10.1161/CIRCEP.114.002105. Epub 2015 Feb 23.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Maladies cardiaques
- Maladies cardiovasculaires
- Maladie du système de conduction cardiaque
- Arythmies cardiaques
- Tachycardie
- Tachycardie ventriculaire
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Radiopharmaceutiques
- 3-Iodobenzylguanidine
Autres numéros d'identification d'étude
- HP-00043324
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