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- Essai clinique NCT04930510
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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Florence Leclercq, PU PH
- Numéro de téléphone: 33 4.67.33.67.33
- E-mail: f-leclercq@chu-montpellier.fr
Lieux d'étude
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Montpellier, France, 34295
- Recrutement
- UHMontpellier
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Contact:
- Florence Leclercq, PUPH
- Numéro de téléphone: 33 04.67.33.67.33
- E-mail: f-leclercq@chu-montpellier.fr
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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:
- 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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Comparison of the incidence of major cardio-vascular event
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Incidence of CAD
Délai: 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
|
1 year
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Length of hospitalisation
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Florence Leclercq, PU PH, University Hospital, Montpellier
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
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
- Maladies cardiaques
- Maladies cardiovasculaires
- Maladies vasculaires
- Artériosclérose
- Maladies artérielles occlusives
- Maladie de la valve aortique
- Maladies des valves cardiaques
- Obstruction de la sortie ventriculaire
- Maladie de l'artère coronaire
- Ischémie myocardique
- Maladie coronarienne
- Sténose valvulaire aortique
Autres numéros d'identification d'étude
- RECHMPL21_0208
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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