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Coronary Artery Disease in Elderly People Referred for TAVI (CEPTAVI)

10. juni 2021 opdateret af: University Hospital, Montpellier

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

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

170

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

80 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients aged of 80 years or over who are admitted in cardiology for TAVI

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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
Group 2 : No significant coronary disease group
No significant coronary disease group in the cohort of elderly 80 years or over referred for TAVI

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comparison of the incidence of major cardio-vascular event
Tidsramme: 1 year

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:

  • Death (total and cardiovascular)
  • ischemic stroke,
  • haemorrhagic stroke,
  • acute coronary syndrome,
  • severe angina (> class 2),
  • major bleeding or vascular complications (>BARC2),
  • Re-hospitalisation for cardiac events
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of CAD
Tidsramme: 1 year
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
Length of hospitalisation
Tidsramme: 1 year

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
Rate of ischaemic
Tidsramme: 1 year
ischaemic event (acute coronary syndrome, severe angina)
1 year
Rate of vascular/bleeding events according to strategy of care (PCI/no PCI)
Tidsramme: 1 year
minor bleeding (BARC 1 and 2) and major (BARC 3 et 4) event or vascular complication (VARC 2).
1 year
Re-hospitalization for cardiac events
Tidsramme: 1 year
Re-hospitalization for cardiac events
1 year
Quality of life with assessment of clinical status
Tidsramme: 1 year
Quality of life with assessment of clinical status by geriatrics tests geriatrics tests by phone interview of the patient
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Montpellier

Efterforskere

  • Studieleder: Florence Leclercq, PU PH, University Hospital, Montpellier

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2020

Primær færdiggørelse (Forventet)

1. november 2022

Studieafslutning (Forventet)

1. november 2023

Datoer for studieregistrering

Først indsendt

25. maj 2021

Først indsendt, der opfyldte QC-kriterier

10. juni 2021

Først opslået (Faktiske)

18. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2021

Sidst verificeret

1. maj 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RECHMPL21_0208

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

IPD-planbeskrivelse

NC

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