Cardiac Output, Cerebral Perfusion and Cognition in Patients Undergoing TAVI

NCT05481008 | Unknown

• 1 other identifier: NL72247.018.19
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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)

  Change from baseline (pre-tavi) to 3 months

• Potential negative cerebral outcomes as a consequence of TAVI induced cerebral embolization

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

  Change from baseline (pre-tavi) to 3 months

Secondary Outcomes (4)

• Cognitive functioning

  Change from baseline (pre-tavi) to 3 months

• Cognitive functioning

  1 year

• Cardiac output

  Change from baseline (pre-tavi) to 3 months

• Cardiac output

  1 year

Interventions

transcatheter aortic valve implantation DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ronak Delewi: lead

Study Sites (1)

Amsterdam Universitair Medisch Centrum (AUMC) - Locatie AMC

Amsterdam, North Holland, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 37910335 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Cognitive Dysfunction

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Central Study Contacts

Astrid van Nieuwkerk, MD

CONTACT

0031205666603; a.vannieuwkerk@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD, Prinicipal Investigator

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: July 29, 2022
• Study Start: August 28, 2020
• Primary Completion: November 1, 2022
• Study Completion: August 1, 2023
• Last Updated: July 29, 2022

Record last verified: 2022-07

Locations

NL (1)