Cardiac Output, Cerebral Perfusion and Cognition in Patients Undergoing TAVI

NCT ID: NCT05481008

Last Updated: 2022-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 142 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-28
• Study Completion Date: 2023-08-31

Brief 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 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.

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).

Conditions

Aortic Valve Stenosis; Cognitive Impairment; Cognitive Change

Keywords

Transcatheter aortic valve implantation; Aortic valve stenosis; Cognitive impairment; Cognition; Cerebral perfusion; Cerebral blood flow

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

transcatheter aortic valve implantation

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ronak Delewi

OTHER

Sponsor Role: lead

Responsible Party

Ronak Delewi

MD PhD, Prinicipal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Amsterdam Universitair Medisch Centrum (AUMC) - Locatie AMC

Amsterdam, North Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Astrid van Nieuwkerk, MD

Role: CONTACT

Phone: 0031205666603

Email: a.vannieuwkerk@amsterdamumc.nl

Facility Contacts

Astrid van Nieuwkerk, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 37910335 (View on PubMed)

Other Identifiers

NL72247.018.19

Identifier Type: -

Identifier Source: org_study_id