Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04930510
Status:
UNKNOWN
Last Update Posted:
2021-06-18
First Post:
2021-05-25
Brief Title:
Coronary Artery Disease in Elderly People Referred for TAVI
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
IncIncidence and Prognosis of Coronary Artery Disease in Elderly People Over 80 Years Referred for TAVI
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CEPTAVI
Brief Summary:
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
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
Detailed Description:
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 its proposed by the formula p 1962 x p1-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 patients validity will be check by calling his caregiver andor his general practitioner if caregiver not available
Analysis associated of the computerized patient record
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 its proposed by the formula p 1962 x p1-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 patients validity will be check by calling his caregiver andor his general practitioner if caregiver not available
Analysis associated of the computerized patient record
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None