Can Exercise Electrocardiography Discriminate Hypertensive Heart Disease From Obstructive Coronary Artery Disease? A Multimodality Imaging Study (HYSTERESIS)
To evaluate the ability of exercise ECG to discriminate between hypertensive heart disease-related and CAD-related abnormalities
Descripción general del estudio
Estado
Descripción detallada
In this prospective study, consecutive patients undergoing evaluation for suspected coronary artery disease will undergo exercise ECG testing (ExECG), transthoracic echocardiography (TTE), stress cardiac magnetic resonance (CMR), and coronary computed tomography angiography (CCTA).
Patients will be stratified into four groups according to the presence or absence of LVH and obstructive CAD:
LVH with obstructive CAD LVH without obstructive CAD No LVH with obstructive CAD No LVH without obstructive CAD
LVH will be defined by standard echocardiographic criteria, while obstructive CAD will be assessed by CCTA. Stress CMR will serve as the reference standard for inducible myocardial ischemia.
Exercise ECG parameters will include conventional ST-segment criteria as well as dynamic indices during exercise and recovery. Associations between ECG findings and imaging-defined phenotypes will be evaluated, and predictors of CAD-related ischemia will be identified.
Results The study will assess the diagnostic performance of exercise ECG across the four predefined groups. Differences in ECG response patterns will be compared according to the presence of LVH and obstructive CAD. Multivariable analysis will be performed to identify independent ECG predictors associated with obstructive CAD and inducible ischemia.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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PI
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Pisa, PI, Italia, 56124
- Reclutamiento
- Azienda Ospedaliero-Universitaria Pisana
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Contacto:
- Mattia Alberti, MD, PhD candidate
- Número de teléfono: +39 3770805335
- Correo electrónico: mattia.alberti@phd.unipi.it
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Contacto:
- Morrone Doralisa, MD, PhD, Associate Professor
- Correo electrónico: doralisa.morrone@unipi.it
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Sub-Investigador:
- Riccardo Canonaco, MD
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Sub-Investigador:
- Simona Chiusolo, MD
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Sub-Investigador:
- Simona Buralli, MD
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Sub-Investigador:
- Stefano Taddei, MD, Full Professor
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Sub-Investigador:
- Emanuele Neri, MD, Full Professor
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Sub-Investigador:
- Giovanni Donato Aquaro, MD, PhD, Associate Professor
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Sub-Investigador:
- Lorenzo Faggioni, MD, Associate Professor
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Sub-Investigador:
- Doralisa Morrone, MD, PhD, Associate Professor
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Sub-Investigador:
- Raffaele De Caterina, MD, PhD, Full Professor
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Sub-Investigador:
- Pietro Lucii, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
consecutive patients undergoing evaluation for suspected coronary artery disease will undergo exercise ECG testing (ExECG), transthoracic echocardiography (TTE), stress cardiac magnetic resonance (CMR), and coronary computed tomography angiography (CCTA).
Patients will be stratified into four groups according to the presence or absence of LVH and obstructive CAD:
LVH with obstructive CAD LVH without obstructive CAD No LVH with obstructive CAD No LVH without obstructive CAD
Descripción
Inclusion Criteria:
- Patients with CAD and LVH
Exclusion Criteria:
- Patients with RBBB
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
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LVH with obstructive CAD
LVH with obstructive CAD |
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LVH without obstructive CAD
LVH without obstructive CAD |
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No LVH with obstructive CAD
No LVH with obstructive CAD |
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No LVH without obstructive CAD
No LVH without obstructive CAD |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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diagnostic performance of exercise ECG across the four predefined groups.
Periodo de tiempo: From enrollment through completion of all diagnostic evaluations, assessed up to 3 months after enrollment.
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Differences in ECG response patterns will be compared according to the presence of LVH and obstructive CAD. Multivariable analysis will be performed to identify independent ECG predictors associated with obstructive CAD and inducible ischemia. |
From enrollment through completion of all diagnostic evaluations, assessed up to 3 months after enrollment.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HYSTERESIS
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual participant data (IPD) will be made available upon reasonable request following the completion of all planned analyses and subsequent publication of the resulting manuscripts
Información sobre medicamentos y dispositivos, documentos del estudio
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