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

Postoperative Cognitive Dysfunction Clinical Trial

— CardChNeuroMRI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01622452
• Other study ID #: 396/12 FTGM
• Status: Not yet recruiting
• Phase: N/A
• First received: June 15, 2012
• Last updated: August 14, 2013
• Start date: October 2013
• Est. completion date: October 2016

Study information

• Verified date: August 2013
• Source: Fondazione Toscana Gabriele Monasterio
• Contact: Domenico Montanaro, MD
• Phone: +390585493564
• Email: domenico.montanaro[@]ftgm.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cognition Disorders
• Postoperative Cognitive Dysfunction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Toscana Gabriele Monasterio

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No