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

NCT01622452 | Unknown

• 1 other identifier: 396/12 FTGM
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Cognitive Dysfunction

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Brain MRI microstructural/functional alteration due to cardiac surgery in association with POCD

  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.

  32 months

• Brain MRI metabolic alteration due to cardiac surgery in association with POCD

  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.

  32 months

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing elective valve surgery in Ospedale del Cuore, Fondazione G. Monasterio, Massa, Italy and matching inclusion/exclusion criteria will prospectively enter the study.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Toscana Gabriele Monasterio: lead

MeSH Terms

Conditions

Postoperative Cognitive Complications; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Domenico Montanaro, MD

CONTACT

+390585493564; domenico.montanaro@ftgm.it

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsible of the Neuroradiological Unit, Foundation CNR - Regione Toscana G. Monasterio

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: June 19, 2012
• Study Start: October 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 15, 2013

Record last verified: 2013-08