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

NCT ID: NCT01622452

Last Updated: 2013-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Cognitive Dysfunction

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Toscana Gabriele Monasterio

OTHER

Sponsor Role lead

Responsible Party

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Montanaro Domenico

Responsible of the Neuroradiological Unit, Foundation CNR - Regione Toscana G. Monasterio

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Domenico Montanaro, MD

Role: CONTACT

+390585493564

Other Identifiers

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396/12 FTGM

Identifier Type: -

Identifier Source: org_study_id

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