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

Neurocognitive Deficits Related to Cardiac Surgery Intervention With Extracorporeal Circulation. Correlations Between Neuropsychological Tests and Functional MRI Techniques (Spectroscopy, Diffusion and Morphometry)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01622452

Acronym

CardChNeuroMRI

Enrollment

Registered

2012-06-19

Start date

2013-10-31

Completion date

2016-10-31

Last updated

2013-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Cognitive Dysfunction

Keywords

Postoperative cognitive dysfunction, Cognitive decline, Valve surgery, Cardiac surgery, Diffusion Tensor Imaging, Brain Morphometry, 1H-Magnetic Resonance Spectroscopy

Brief summary

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

35 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Brain MRI microstructural/functional alteration due to cardiac surgery in association with POCD	32 months	On the basis of scientific literature, the patients during the first post-cardiosurgical week can show cognitive dysfunction in 40-70% of the cases, decreasing after 6 weeks to 10-40%, remaining stable over the long-term. To identify corresponding brain specific microstructural variations, simultaneously to the neuropsychological evaluation, the same group of patients will undergo to MRI with standard sequence and advanced morpho-structural methods (DTI and VBM). Comparing data with a group of healthy age-matched subjects (20), quantitative measurements by VBM and DTI will be carried out to identify GM and WM variations, subsequently correlated with onset of POCD.
Brain MRI metabolic alteration due to cardiac surgery in association with POCD	32 months	To explore pre- and post- operative metabolic changes on the brain using in-vivo proton magnetic resonance spectroscopy (1H-MRS) after otherwise successful cardiac surgery with no major neurological event.

Contacts

Primary ContactDomenico Montanaro, MD

domenico.montanaro@ftgm.it+390585493564

Outcome results