Coronary Artery Disease in Elderly People Referred for TAVI (CEPTAVI)
IncIncidence and Prognosis of Coronary Artery Disease in Elderly People Over 80 Years Referred for TAVI
The investigators prognostic impact of coronary artery disease (CAD) and of percutaneous coronary intervention (PCI) in patients with indication of TAVI is controversial, particularly in elderly population where CAD and aortic stenosis (AS) are frequent and commonly coexisted. (1-2) The primary end point of this prospective study is to compare major cardiovascular event at one year of follow up in patients over 80 years with severe aortic stenosis who referred for TAVI with or without associated CAD.
The investigators will also assess (secondary endpoint) the impact of PCI on symptoms, major events and quality of life using geriatric parameters. The study will be conducted in the University hospital of Montpellier between November 2020 and November 2022
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Patients will be prospectively included in the study when aged of 80 years old or over and referred for TAVI at the university hospital of Montpellier.
Two groups of patients will be considered after coronary angiography which is systematic before TAVI Group 1: patients with significant > 50 % narrowing coronary stenosis ( revascularization by PCI / no revascularization) Group 2: No coronary lesion
Considering an end point at 1 year and a precision wished to i ± 6 percent with an alpha risk of 5 %, it's proposed , by the formula p= [(1.96)2 x [p(1-p)] / i2 ], a number of 170 subjects needed to highlight a incidence of major cardio-vascular event of 20 percent in the studied population.
Data collection by informatic files will include :
- Cardio vascular risk factor and medical history with evaluation of Charlston score
- Previous drug therapy
- Lifestyle : living alone or not, nursing home, ; home help
- Symptoms (angina (CSS classification) ; dyspnea (NHYA classification))
- Renal function (DFG) at admission
- Results of coronary angiography (number of lesions, proximal or non proximal, location of coronary stenosis)
- Geriatric assessment : autonomy, disability in daily living, weigh, BMI, falls, cognitive functions tests, assessment of the mood state by GDS
- Results of TAVI (success and complications of the procedure according to VARC2 criteria)
- Results of coronary revascularization if performed
- Length of hospitalisation for TAVI (days), length of stay in ICU (Intensive Care Unit) if necessary
- Events during the hospitalisation for TAVI (VARC and BARC criterias)
Follow up at 6 month (middle analysis) and at one year (primary end point) by phone conversation with the patient for assessment of :
- Major cardio-vascular events
- Hospitalisation occurred
Short geriatric evaluation including :
- cognition by Ottawa3DY
- autonomy by ADL
- polypharmacy
- number of fall in the past 6 month
- last weight
- quality of life (Fried criterias)
- mood state by GDS If neurocognitive disorders are known or discovers, data patient's validity will be check by calling his caregiver and/or his general practitioner (if caregiver not available).
Analysis associated of the computerized patient record.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Florence Leclercq, PU PH
- Número de teléfono: 33 4.67.33.67.33
- Correo electrónico: f-leclercq@chu-montpellier.fr
Ubicaciones de estudio
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Montpellier, Francia, 34295
- Reclutamiento
- Uhmontpellier
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Contacto:
- Florence Leclercq, PUPH
- Número de teléfono: 33 04.67.33.67.33
- Correo electrónico: f-leclercq@chu-montpellier.fr
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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
Descripción
Inclusion criteria:
- patient aged 80 and over
- hospital admission for evaluation before TAVI indicated for symptomatic and severe aortic stenosis
- patient's consent
Exclusion criteria:
- absence of coronarography
- severe angina (class 3 or 4)
- stenosis of left main coronary artery > 50%
- stenosis of the left anterior descending artery > 90%
- decision of surgical valve replacement
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Group 1 : Elderly 80 years or over patients referred for TAVI with CAD
Elderly 80 years or over patients referred for TAVI with CAD Group 1: Coronary lesion defined as significant (>50% narrowing) on the coronary angiography performed before TAVI, with or without PCI (decision of the heart team) Description of the coronary lesions included: proximal/non proximal, number of lesions, location of lesion
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Group 2 : No significant coronary disease group
No significant coronary disease group in the cohort of elderly 80 years or over referred for TAVI
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Comparison of the incidence of major cardio-vascular event
Periodo de tiempo: 1 year
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Comparison of the incidence of major cardio-vascular event at one year follow up in elderly 80 or over referred for TAVI with (group 1) or without CAD (group 2). Major cardio vascular events evaluated at 1 year follow-up include:
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1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of CAD
Periodo de tiempo: 1 year
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Incidence of CAD in the elderly over 80 years old during the pre TAVI evaluation Evaluate the coronary disease impact in the elderly over 80 referred for TAVI by the number of patients over 80 years with significant coronary lesions compared to global TAVI population over 80 years
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1 year
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Length of hospitalisation
Periodo de tiempo: 1 year
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Length of hospitalisation with or without coronary disease, with or without PCI. Length of hospitalisation in total and in the ICU if it's happened to evaluated the economic impact of CAD and therapeutic strategy. |
1 year
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Rate of ischaemic
Periodo de tiempo: 1 year
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ischaemic event (acute coronary syndrome, severe angina)
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1 year
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Rate of vascular/bleeding events according to strategy of care (PCI/no PCI)
Periodo de tiempo: 1 year
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minor bleeding (BARC 1 and 2) and major (BARC 3 et 4) event or vascular complication (VARC 2).
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1 year
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Re-hospitalization for cardiac events
Periodo de tiempo: 1 year
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Re-hospitalization for cardiac events
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1 year
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Quality of life with assessment of clinical status
Periodo de tiempo: 1 year
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Quality of life with assessment of clinical status by geriatrics tests geriatrics tests by phone interview of the patient
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1 year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Florence Leclercq, PU PH, University Hospital, Montpellier
Publicaciones y enlaces útiles
Publicaciones Generales
- Cao D, Chiarito M, Pagnotta P, Reimers B, Stefanini GG. Coronary Revascularisation in Transcatheter Aortic Valve Implantation Candidates: Why, Who, When? Interv Cardiol. 2018 May;13(2):69-76. doi: 10.15420/icr.2018:2:2.
- Matta AG, Lhermusier T, Parada FC, Bouisset F, Canitrot R, Nader V, Blanco S, Elbaz M, Roncalli J, Carrie D. Impact of Coronary Artery Disease and Percutaneous Coronary Intervention on Transcatheter Aortic Valve Implantation. J Interv Cardiol. 2021 Mar 24;2021:6672400. doi: 10.1155/2021/6672400. eCollection 2021.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Términos MeSH relevantes adicionales
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Enfermedad de la válvula aórtica
- Enfermedades de las válvulas cardíacas
- Obstrucción del flujo de salida ventricular
- Enfermedad de la arteria coronaria
- Isquemia miocardica
- Enfermedad coronaria
- Estenosis de la válvula aórtica
Otros números de identificación del estudio
- RECHMPL21_0208
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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