Postoperative Cognitive DysfunctionCardChNeuroMRINCT01622452
Post Cardiac Surgery Neurocognitive Decline: Correlations Between Neuropsychological Tests and Functional MRI Techniques
An observational study of Postoperative Cognitive Dysfunction, run by Fondazione Toscana Gabriele Monasterio.
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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients undergoing elective valve surgery in Ospedale del Cuore, Fondazione G. Monasterio, Massa, Italy will prospectively enter the study.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- Postoperative cognitive dysfunction, Cognitive decline, Valve surgery, Cardiac surgery, Diffusion Tensor Imaging, Brain Morphometry, 1H-Magnetic Resonance Spectroscopy
- Medical subject headings
- Postoperative Cognitive Complications, Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startOct 2013
- Primary completionJul 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Toscana Gabriele Monasterio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montanaro Domenico, Fondazione Toscana Gabriele Monasterio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622452
- Sponsor's protocol ID
- 396/12 FTGM
- Acronym
- CardChNeuroMRI
- Status last verified
- Aug 2013
- First submitted
- 15 Jun 2012
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Deficits Related to Cardiac Surgery Intervention With Extracorporeal Circulation. Correlations Between Neuropsychological Tests and Functional MRI Techniques (Spectroscopy, Diffusion and Morphometry)
- ClinicalTrials.gov ID
- NCT01622452
- Acronym / sponsor ID
- CardChNeuroMRI / 396/12 FTGM
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- Postoperative cognitive dysfunction, Cognitive decline, Valve surgery, Cardiac surgery, Diffusion Tensor Imaging, Brain Morphometry, 1H-Magnetic Resonance Spectroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione Toscana Gabriele MonasterioUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 19 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients undergoing elective valve surgery in Ospedale del Cuore, Fondazione G. Monasterio, Massa, Italy will prospectively enter the study.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction, run by Fondazione Toscana Gabriele Monasterio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Domenico Montanaro, MD (+390585493564, domenico.montanaro@ftgm.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain MRI microstructural/functional alteration due to cardiac surgery in association with POCD (time frame: 32 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2013.