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Aortic Valve StenosisCAPITANCT05481008

Cardiac Output, Cerebral Perfusion and Cognition in Patients Undergoing TAVI

An observational study of Aortic Valve Stenosis and Cognitive Impairment, run by Ronak Delewi at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Rationale: Cardiovascular disease and cognitive diseases are closely related. Cognitive impairment is common (21-39%) among patients with severe aortic valve stenosis. The proof-of-concept CP-TAVI study showed that increased cardiac output following transcatheter aortic valve implantation (TAVI) was associated with… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
transcatheter aortic valve implantation
Type of treatment
Medical device
How many people
142 participants
Where
1 siteNetherlands
Study dates
28 Aug 2020to Aug 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: N=142 patients with symptomatic severe aortic valve stenosis selected for transcatheter aortic valve implantation

Who may be able to join

  • Severe aortic valve stenosis (aortic valve area <1cm2 and/or mean aortic valve gradient exceeds 50 mmHg) of a native valve
  • Eligible for TAVI
  • Able and willing to give informed consent
  • Age > 18 years

Who cannot join

  • Presence of MRI contra-indication; inability to lay flat for 30 minutes
  • Weight > 130 kg
  • Neurological disease
  • Active malignant disease;
  • Insufficient mastery of the Dutch language
  • Inability to withdraw from alcohol use for 24 hours
  • Non-atherosclerotic vascular disease (eg vasculitis)
  • Planned surgery with general anesthesia within three months after TAVI.

Trial locations and contacts

1 site in 1 country.

Astrid van Nieuwkerk, MD contact

0031205666603

a.vannieuwkerk@amsterdamumc.nl

Netherlands1 site, 1 recruiting

  • Amsterdam Universitair Medisch Centrum (AUMC) - Locatie AMC

    Amsterdam, North Holland

    Astrid van Nieuwkerk, MD, a.vannieuwkerk@amsterdamumc.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Cardiac Output, Cerebral Perfusion and Cognition in Patients With Severe Aortic Valve Stenosis Undergoing Transcatheter Aortic Valve Implantation

Rationale: Cardiovascular disease and cognitive diseases are closely related. Cognitive impairment is common (21-39%) among patients with severe aortic valve stenosis. The proof-of-concept CP-TAVI study showed that increased cardiac output following transcatheter aortic valve implantation (TAVI) was associated with increased cerebral blood flow. It is hypothesized that increased cerebral blood flow (CBF) subsequently leads to improved cognitive functioning. Additionally, silent micro emboli caused by crushing of the calcified native valve during TAVI may cause cognitive deterioration. If it could be predicted which patients are at risk for TAVI induced cerebral micro emboli, these patients could benefit from cerebral protection devices, preventing cognitive decline.

Objective: The objectives of the CAPITA study are 1A) to identify whether an increase in cardiac output after TAVI is associated with an increase of global CBF; 1B) explore regional differences in CBF after TAVI; 1C) determine whether (global or regional) increased CBF is associated with improved cognitive functioning; 1D) identify patient and procedural characteristics associated with increased cardiac output, CBF and cognitive functioning; 2A) identify the incidence and volume of new white matter hyperintensities after TAVI; 2B) evaluate patient and procedural predictors for the increase in white matter hyperintensities volume, including baseline aortic valve calcification volume, measured with computed tomography; 2C) if aortic valve calcification volume predicts new white matter hyperintensities, define a cut-off value for high-risk patients; 2D) assess whether the increase in white matter hyperintensity volume is associated with deterioration of cognitive scores.

Read more

Study design: Prospective observational study, measuring cardiac output (echocardiography), cerebral blood flow (arterial spin labelling magnetic resonance imaging) and cognitive functioning (neuropsychological test battery) prior to TAVI (<24 hours to <one week) and at 3 months follow-up. At one year follow-up, cardiac output and cognitive function will be assessed.

Study population: Patients with severe aortic valve stenosis eligible for transfemoral TAVI (n=142).

Main study parameters/endpoints: Cardiac output (L/min), cerebral blood flow (mL/100g/min, change in %, relative to baseline) and cognitive functioning (extensive neuropsychological testing 60-90 minutes).

Being tested
transcatheter aortic valve implantation
Keywords
Transcatheter aortic valve implantation, Aortic valve stenosis, Cognitive impairment, Cognition, Cerebral perfusion, Cerebral blood flow
Medical subject headings
Aortic Valve Stenosis, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transcatheter aortic valve implantationDevice

    All subjects undergo transcatheter aortic valve implantation because of symptomatic severe aortic valve stenosis. This is a routine medical procedure, not a study intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Potential positive cerebral effects generated by an increase in cerebral blood flow after TAVI

    Cerebral blood flow (mL/100g/min, change in %, relative to baseline) as measured on arterial spin labelling magnetic resonance imaging)

    Measured: Change from baseline (pre-tavi) to 3 months

  2. Potential negative cerebral outcomes as a consequence of TAVI induced cerebral embolization

    New white matter hyperintensities (number and volume [mL]) and (micro) bleeds

    Measured: Change from baseline (pre-tavi) to 3 months

Secondary outcomes (4)

  1. Cognitive functioning

    Cognitive functioning on various domains. As measured by a standardized extensive neuropsychological test battery (60-90 minutes) performed by a trained neuropsychologist.

    Measured: Change from baseline (pre-tavi) to 3 months

  2. Cognitive functioning

    Cognitive functioning on various domains. As measured by a standardized extensive neuropsychological test battery (60-90 minutes) performed by a trained neuropsychologist.

    Measured: 1 year

  3. Cardiac output

    Cardiac output (L/min) as measured on echocardiography (LVOT VTI)

    Measured: Change from baseline (pre-tavi) to 3 months

  4. Cardiac output

    Cardiac output (L/min) as measured on echocardiography (LVOT VTI)

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2022
  2. Study start28 Aug 2020
  3. Primary completionNov 2022 (estimated)
  4. Study completionAug 2023 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
142 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05481008
Sponsor's protocol ID
NL72247.018.19
Acronym
CAPITA
Status last verified
Jul 2022
First submitted
11 Apr 2022
Last updated
29 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • van Nieuwkerk AC, Hemelrijk KI, Bron EE, Leeuwis AE, Majoie CBLM, Daemen MJAP, Moonen JEF, de Sitter A, Bouma BJ, van der Flier WM, Baan J, Piek JJ, Biessels GJ, Delewi R; Heart-Brain Connection Consortium. Cardiac output, cerebral blood flow and cognition in patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation: design and rationale of the CAPITA study. Neth Heart J. 2023 Dec;31(12):461-470. doi: 10.1007/s12471-023-01826-8. Epub 2023 Nov 1.

    PubMed 37910335

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Valve Stenosis and Cognitive Impairment, run by Ronak Delewi at 1 site in Netherlands.

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 4 inclusion and 8 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 29 Jul 2022. 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 Netherlands. 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 Astrid van Nieuwkerk, MD (0031205666603, a.vannieuwkerk@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Potential positive cerebral effects generated by an increase in cerebral blood flow after TAVI (time frame: Change from baseline (pre-tavi) to 3 months). The study lists 2 primary outcomes in all. 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 NCT05481008, which also lists 1 linked publication.

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 29 Jul 2022.

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