Postoperative Cognitive DysfunctionNCT02164669
Exploration of Neuroimaging and Biochemical Prognostic Indicators for POCD
An observational study of Postoperative Cognitive Dysfunction and Cognitive Impairment, run by wangqiang at 1 site in China.
Trial summary
Postoperative cognitive dysfunction (POCD) may lead to serious consequences. But the underlying mechanisms are still unclear. Blood Oxygen Level Dependent (BOLD) fMRI and biochemical indicators will be used to explore the underlying mechanisms and represent a promising precursory target for diagnosis and treatment of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Cognitive Impairment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- May 2013to Jun 2014
- How long will I take part?
- 7 Days
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will selective undergo Coronary Artery Bypass Grafting (CABG) surgery. Health adult
Who may be able to join
- Aged 18-80 years old
- Underwent selective CABG surgery
Who cannot join
- History of central nervous system or psychiatric disorders
- History of taking sedative, antidepressants, or alcoholism
- MMSE score less than 23
- Visual or auditory disorders
- Educated less than 7 years
- Claustrophobia
- Can not be supine
- Can not tolerate iodinated contrast agents
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijign Hospital
Xi'an, Shaanxi, 710032
Qiang Wang, MD,PhD, +86-29-84775343, wangqiang@fmmu.edu.cn
About this study
Official title: Exploration of Neuroimaging and Biochemical Prognostic Indicators for Post-operative Cognitive Dysfunction After Coronary Artery Bypass Graft
Postoperative cognitive dysfunction (POCD) may lead to serious consequences. But the underlying mechanisms are still unclear. Blood Oxygen Level Dependent (BOLD) fMRI and biochemical indicators will be used to explore the underlying mechanisms and represent a promising precursory target for diagnosis and treatment of POCD.
Read the detailed description
Postoperative cognitive dysfunction (POCD) is one of the most common complications in patients undergoing cardiac surgery. POCD will not only increase the incidence of complications and mortality, but also influence the quality of life after discharging from the hospital. Many factors are associated with POCD, such as neuroinflammation, age, anesthetics, surgery stress response and genetic factors. But the underlying mechanisms are still unclear. Blood Oxygen Level Dependent (BOLD) fMRI, which could monitor the peripheral neuron spontaneous activity according to the ratio of oxyhemoglobin and deaeration hemoglobin in blood, will be used to investigate whether POCD is induced by the variance in neurons metabolism and spontaneous activity in brain regions. Meanwhile, biochemical indicators will be detected to explore the prompting indicators of POCD. The present study is aimed to represent a promising precursory target for diagnosis and treatment of POCD, and provide novel evidence and insights on the brain changes induced by POCD.
- Keywords
- Inflammation, Coronary artery bypass graft, Magnetic Resonance Imaging
- Medical subject headings
- Postoperative Cognitive Complications, Cognitive Dysfunction, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
The brain structure changes
Using BOLD fMRI to investigate the variance of mean diffusivity and FA in nerve conduction bundle
Measured: 7 days postoperatively
Secondary outcomes (1)
Mini-Mental State Examination
Application of digital depth and breadth to test digital sign test Tracking the attachment test and assess depression self rating scale
Measured: preoperative and 7 days, 3 months and 1 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startMay 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- wangqiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, wangqiang, Xijing Hospital
- Investigators
- Qiang Wang, MD, PhD, Study director, Xijing HospitalZijun Gao, Dr., Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164669
- Sponsor's protocol ID
- 20130225-8
- Status last verified
- May 2013
- First submitted
- 12 Jun 2014
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Neuroimaging and Biochemical Prognostic Indicators for Post-operative Cognitive Dysfunction After Coronary Artery Bypass Graft
- ClinicalTrials.gov ID
- NCT02164669
- Acronym / sponsor ID
- 20130225-8
- Keywords
- Inflammation, Coronary artery bypass graft, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- wangqiangUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 16 Jun 2014 (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 dysfunction (POCD) may lead to serious consequences. But the underlying mechanisms are still unclear. Blood Oxygen Level Dependent (BOLD) fMRI and biochemical indicators will be used to explore the underlying mechanisms and represent a promising precursory target for diagnosis and treatment of POCD.
Detailed description
Postoperative cognitive dysfunction (POCD) is one of the most common complications in patients undergoing cardiac surgery. POCD will not only increase the incidence of complications and mortality, but also influence the quality of life after discharging from the hospital. Many factors are associated with POCD, such as neuroinflammation, age, anesthetics, surgery stress response and genetic factors. But the underlying mechanisms are still unclear. Blood Oxygen Level Dependent (BOLD) fMRI, which could monitor the peripheral neuron spontaneous activity according to the ratio of oxyhemoglobin and deaeration hemoglobin in blood, will be used to investigate whether POCD is induced by the variance in neurons metabolism and spontaneous activity in brain regions. Meanwhile, biochemical indicators will be detected to explore the prompting indicators of POCD. The present study is aimed to represent a promising precursory target for diagnosis and treatment of POCD, and provide novel evidence and insights on the brain changes induced by POCD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will selective undergo Coronary Artery Bypass Grafting (CABG) surgery. Health adult
Key inclusion criteria (2 listed)
- Aged 18-80 years old
- Underwent selective CABG surgery
Key exclusion criteria (8 listed)
- History of central nervous system or psychiatric disorders
- History of taking sedative, antidepressants, or alcoholism
- MMSE score less than 23
- Visual or auditory disorders
- Educated less than 7 years
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
The brain structure changes
Time frame: 7 days postoperatively
Using BOLD fMRI to investigate the variance of mean diffusivity and FA in nerve conduction bundle
1 secondary outcome
Mini-Mental State Examination
Time frame: preoperative and 7 days, 3 months and 1 years postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2014.
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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.
Qiang Wang, MD, PhD study director
Xijing Hospital
Zijun Gao, Dr. principal investigator
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction and Cognitive Impairment, run by wangqiang at 1 site in China.
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 2 inclusion and 8 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 16 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Qiang Wang, MD,PhD (+86-29-84775343, Wangqiang@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The brain structure changes (time frame: 7 days postoperatively). 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 16 Jun 2014.