- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02141269
Comparitive Effectiveness of PME Versus Transthoracic Echocardiogram (TTE)
Comparative Effectiveness of Pocket, Mobile, Hand-held Echocardiography and Conventional Transthoracic Echocardiography in an Inpatient and Outpatient Clinical Setting
A new hand held pocket echo device (GE Vscan) has now become available to clinicians, with limited data available comparing the effectiveness of this device as a screening tool when compared to traditional transthoracic echocardiography (TTE).
The investigators are evaluating the effectiveness of this hand-held echo (HHE) device in detecting cardiac pathology in a both an inpatient and outpatient clinical setting as compared to a comprehensive TTE evaluation.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
A new hand held pocket echo device (GE Vscan) has now become available to clinicians, with limited data available comparing the effectiveness of this device as a screening tool when compared to TTE.
We are evaluating the effectiveness of this HHE device in detecting cardiac pathology in a both an inpatient and outpatient clinical setting as compared to a comprehensive TTE evaluation.
This study compares the images from the two modalities with regards to multiple parameters typically evaluated by traditional TTE. This would include the following:
- Ejection fraction: estimates how well the heart is squeezing/functioning.
- Segmental wall motion abnormalities: if one wall of the heart is not moving well, this suggests that part of the heart is not getting enough blood supply and could represent a blockage in a blood vessel supplying the heart or in other terms a heart attack.
- Left ventricular end-diastolic dimension: allows us to see if the heart is dilated
- Inferior vena cava size: the size of this great vein can help estimate if patient has too much fluid in their vascular bed.
- Aortic valve pathology: whether or not there is thickening of the valve or impairment of it's opening.
- Mitral valve pathology: whether or not the valve is significantly thickened or with impaired closing and opening.
- Pericardial effusion: excessive fluid in the sack around the heart.
The images obtained on the HHE will be evaluated by two experienced echocardiographers as well as two cardiology fellows who have obtained training in image acquisition and interpretation. The readers of the HHE images are blinded to the TTE results, and vice versa.
A comparison of these individual parameters on HHE and TTE allows us to validate this new, convenient screening tool in detecting cardiac pathology.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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California
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La Jolla, California, États-Unis, 92037
- Scripps Green Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- All subjects with an order for a routine transthoracic echocardiogram based on clinical indications.
- Vscan images will be obtained to evaluate multiple parameters (noted on research summary).
- Immediately after Vscan imaging, a complete transthoracic echocardiogram will be performed.
- Images will be compared between the Vscan device and the traditional transthoracic echocardiogram.
Exclusion Criteria:
- Subjects who had a limited transthoracic echocardiography (i.e limited views)
- Vscan imaging not attempted for a certain parameter
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Comparison of HHE and TTE results
Délai: 1 time
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Comparison of the two modalities includes accuracy, sensitivity, specificity, proportion visualized, and inter-observer variability.
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1 time
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Eric Topol, MD, Scripps Health
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 (Estimation)
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
Autres numéros d'identification d'étude
- 12-5906
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