ClinicalTrials.Veeva

Menu

Post Cardiac Surgery Neurocognitive Decline: Correlations Between Neuropsychological Tests and Functional MRI Techniques (CardChNeuroMRI)

F

Fondazione Toscana Gabriele Monasterio

Status

Unknown

Conditions

Postoperative Cognitive Dysfunction

Study type

Observational

Funder types

Other

Identifiers

NCT01622452
396/12 FTGM

Details and patient eligibility

About

Postoperative cognitive decline (POCD) is a frequent complication after cardiac surgery. It is estimated that 40-70% of all cardiac patients show cognitive dysfunction during the first post-surgical week. Six weeks after surgery, this incidence decreases to 10-40% and the figure remains stable over the long-term.

The investigators will recruit 50 patients undergoing elective valve surgery and each patient will receive complete evaluation a) preoperative, one week before surgery; b) early postoperative, before hospital discharge; and c) late postoperative, 8 weeks follow up.

The investigators will apply Diffusion Tensor Imaging, 1Proton-Magnetic Resonance Spectroscopy and Morphometry studies with correlation to neuropsychological test battery to evaluate POCD.

Enrollment

50 estimated patients

Sex

All

Ages

35 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients undergoing elective valve surgery in Ospedale del Cuore, Fondazione G. Monasterio, Massa, Italy will prospectively enter the study.

Exclusion criteria

  • History of head trauma, seizures, stroke, carotid artery stenosis (>70%)
  • History of any major surgery with general anesthesia
  • Preoperative MMSE score less than 23 to exclude patients with dementia and mild cognitive impairment (MCI)
  • Subjects who will be unable to complete the baseline neuropsychological battery due to cognitive impairment, psychiatric disease, substance abuse, blindness, or poor knowledge of Italian language
  • Any major neurological complication after CABG surgery (stroke, seizures, encephalopathy not resolving within few postoperative days)
  • if any contraindications to MRI safety, indicated in local MRI safety protocol

Trial contacts and locations

0

Loading...

Central trial contact

Domenico Montanaro, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems