Aortic StenosisCEPTAVINCT04930510
Coronary Artery Disease in Elderly People Referred for TAVI
An observational study of Aortic Stenosis and Coronary Ang, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Aortic Stenosis, Coronary Ang
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2020to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged of 80 years or over who are admitted in cardiology for TAVI
Who may be able to join
- patient aged 80 and over
- hospital admission for evaluation before TAVI indicated for symptomatic and severe aortic stenosis
- patient's consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Florence Leclercq, PUPH, 04.67.33.67.33 ext. 33, f-leclercq@chu-montpellier.fr
About this study
Official title: 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
Read the 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 %, 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.
- Conditions
- Aortic Stenosis, Coronary Ang
- Keywords
- Patients over 80 years, TAVI, coronary artery disease, quality of life
- Medical subject headings
- Aortic Valve Stenosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the incidence of major cardio-vascular event
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
Measured: 1 year
Secondary outcomes (6)
Incidence of CAD
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
Measured: 1 year
Length of hospitalisation
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.
Measured: 1 year
Rate of ischaemic
ischaemic event (acute coronary syndrome, severe angina)
Measured: 1 year
Rate of vascular/bleeding events according to strategy of care (PCI/no PCI)
minor bleeding (BARC 1 and 2) and major (BARC 3 et 4) event or vascular complication (VARC 2).
Measured: 1 year
Re-hospitalization for cardiac events
Re-hospitalization for cardiac events
Measured: 1 year
Quality of life with assessment of clinical status
Quality of life with assessment of clinical status by geriatrics tests geriatrics tests by phone interview of the patient
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Nov 2020
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Leclercq, PU PH, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930510
- Sponsor's protocol ID
- RECHMPL21_0208
- Acronym
- CEPTAVI
- Status last verified
- May 2021
- First submitted
- 25 May 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
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.
PubMed 29928311Matta 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.
PubMed 33824628
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IncIncidence and Prognosis of Coronary Artery Disease in Elderly People Over 80 Years Referred for TAVI
- ClinicalTrials.gov ID
- NCT04930510
- Acronym / sponsor ID
- CEPTAVI / RECHMPL21_0208
- Conditions
- Aortic Stenosis, Coronary Ang
- Keywords
- Patients over 80 years, TAVI, coronary artery disease, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 %, 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged of 80 years or over who are admitted in cardiology for TAVI
Key inclusion criteria (3 listed)
- patient aged 80 and over
- hospital admission for evaluation before TAVI indicated for symptomatic and severe aortic stenosis
- patient's consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of the incidence of major cardio-vascular event
Time frame: 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
6 secondary outcomes
Incidence of CAD
Time frame: 1 year
Length of hospitalisation
Time frame: 1 year
Rate of ischaemic
Time frame: 1 year
Rate of vascular/bleeding events according to strategy of care (PCI/no PCI)
Time frame: 1 year
Re-hospitalization for cardiac events
Time frame: 1 year
Quality of life with assessment of clinical status
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Background: PubMed 29928311Cao 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.
- Background: PubMed 33824628Matta 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.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence Leclercq, PU PH study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis and Coronary Ang, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florence Leclercq, PU PH (4.67.33.67.33 ext. 33, f-leclercq@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the incidence of major cardio-vascular event (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04930510, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.