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

August 14, 2013 updated by: Montanaro Domenico, Fondazione Toscana Gabriele Monasterio

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain MRI microstructural/functional alteration due to cardiac surgery in association with POCD
Time Frame: 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.
32 months
Brain MRI metabolic alteration due to cardiac surgery in association with POCD
Time Frame: 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.
32 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Toscana Gabriele Monasterio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

June 15, 2012

First Submitted That Met QC Criteria

June 18, 2012

First Posted (Estimate)

June 19, 2012

Study Record Updates

Last Update Posted (Estimate)

August 15, 2013

Last Update Submitted That Met QC Criteria

August 14, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 396/12 FTGM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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