Cardiac Surgery PatientsNCT02084030
Screening of Susceptibility Genes in Postoperative Cognitive Dysfunction(POCD)
An observational study of Cardiac Surgery Patients, run by Xijing Hospital at 1 site in China.
Trial summary
The aim of this study is to perform a whole-genome linkage analysis for identification of the susceptibility loci for POCD Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Cardiac Surgery Patients
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Sep 2014
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Old patient(>60 y) who are schedule to receive of-pump cardiac surgery.
Who may be able to join
- Age from 60 to 75 years old;
- Schedule for on-pump cardiac surgery;
- undergoing full intravenous anesthesia;
- without hepatic, renal, pulmonary disease or full intravenous anesthesia surgery history;
- Gave the informed consent.
Who cannot join
- Emergency surgery;
- A history of cerebrovascular disease;
- The history of mental disease;
- Long term use of sedative and antidepressant drugs;
- Alcoholism;
- serious vision, hearing impairment and inapprehensive language;
Show all 9Show fewer
- chromosomal abnormalities;
- blood disease;
- refused to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Hailong Dong, MD,PhD, 86-2984775337, hldong6@hotmail.com
Hailong Dong, MD, PhD
About this study
Official title: Screening of Susceptibility Genes in Postoperative Cognitive Dysfunction After On-pump Cardiac Surgery
The aim of this study is to perform a whole-genome linkage analysis for identification of the susceptibility loci for POCD
Read the detailed description
BACKGROUND: Postoperative cognitive dysfunction is probably the most frequent type of postoperative cognitive impairment. As it mainly affect the elderly population, POCD is receiving increasing attention. However, the pathophysiology of POCD remains incompletely understood. No study had elucidate why somebody are apt to suffer from POCD, but others not. In current study, we try to use GWAS technology to find out whether there is a correlation between POCD and gene specificity.
DESIGNING: 120 patients will be screened who are schedule to receive selective on-pump cardiac surgery， 5 ml blood of the patient will be collected before anesthesia induction. Investigetors will measure the cognitive function of the patients one day before surgery and 7 d after surgery and identify whether the patient suffer from POCD used in MMSE test. Randomly select 36 patients who suffer from POCD and 36 patients without POCD(control), GWAS technology will be used to screen the susceptibility gene between these two groups.
EXPECTED RESULTS ：Find out some susceptibility genes correlate to POCD.
CONCLUSIONS: The patients who are apt to suffer from POCD have some special susceptibility genes differ from normal people.
- Conditions
- Cardiac Surgery Patients
- Keywords
- cardiac surgery, POCD, GWAS, Susceptibility gene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Patient with POCD | Patients who suffer from POCD after surgery. The mini-mental state examination scale decline more than 1 SD of baseline after surgery. | |
| Sham Comparator: patient without POCD | Patients who don't suffer from POCD after surgery. There is no obvious difference between pre-operation and post-operation in mini-mental state examination scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
single nucleotide polymorphisms(SNPs) of each patient
Measured: about 10 minutes before anesthesia induction
Secondary outcomes (1)
mini-mental state examination scale
the cognitive function
Measured: one day before surgery, 7 d after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startMar 2013
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery PatientsStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HailongDong, Xijing Hospital
- Investigators
- Hailong Dong, MD,PhD, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084030
- Sponsor's protocol ID
- DONG2014POCD
- Status last verified
- Aug 2014
- First submitted
- 4 Mar 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Susceptibility Genes in Postoperative Cognitive Dysfunction After On-pump Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02084030
- Acronym / sponsor ID
- DONG2014POCD
- Conditions
- Cardiac Surgery Patients
- Keywords
- cardiac surgery, POCD, GWAS, Susceptibility gene
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 11 Mar 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.
The aim of this study is to perform a whole-genome linkage analysis for identification of the susceptibility loci for POCD
Detailed description
BACKGROUND: Postoperative cognitive dysfunction is probably the most frequent type of postoperative cognitive impairment. As it mainly affect the elderly population, POCD is receiving increasing attention. However, the pathophysiology of POCD remains incompletely understood. No study had elucidate why somebody are apt to suffer from POCD, but others not. In current study, we try to use GWAS technology to find out whether there is a correlation between POCD and gene specificity.
DESIGNING: 120 patients will be screened who are schedule to receive selective on-pump cardiac surgery， 5 ml blood of the patient will be collected before anesthesia induction. Investigetors will measure the cognitive function of the patients one day before surgery and 7 d after surgery and identify whether the patient suffer from POCD used in MMSE test. Randomly select 36 patients who suffer from POCD and 36 patients without POCD(control), GWAS technology will be used to screen the susceptibility gene between these two groups.
EXPECTED RESULTS ：Find out some susceptibility genes correlate to POCD.
CONCLUSIONS: The patients who are apt to suffer from POCD have some special susceptibility genes differ from normal people.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Patient with POCD | – | –Patients who suffer from POCD after surgery. The mini-mental state examination scale decline more than 1 SD of baseline after surgery. |
| Sham Comparator: patient without POCD | – | –Patients who don't suffer from POCD after surgery. There is no obvious difference between pre-operation and post-operation in mini-mental state examination scale |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Old patient(>60 y) who are schedule to receive of-pump cardiac surgery.
Key inclusion criteria (5 listed)
- Age from 60 to 75 years old;
- Schedule for on-pump cardiac surgery;
- undergoing full intravenous anesthesia;
- without hepatic, renal, pulmonary disease or full intravenous anesthesia surgery history;
- Gave the informed consent.
Key exclusion criteria (9 listed)
- Emergency surgery;
- A history of cerebrovascular disease;
- The history of mental disease;
- Long term use of sedative and antidepressant drugs;
- Alcoholism;
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
single nucleotide polymorphisms(SNPs) of each patient
Time frame: about 10 minutes before anesthesia induction
1 secondary outcome
mini-mental state examination scale
Time frame: one day before surgery, 7 d after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 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.
Hailong Dong, MD,PhD 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 Cardiac Surgery Patients, run by Xijing Hospital 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 5 inclusion and 9 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 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 Hailong DONG, MD, PhD (86-2984775337, hldong6@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
single nucleotide polymorphisms(SNPs) of each patient (time frame: about 10 minutes before anesthesia induction). 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 2014; AzTrials last refreshed its copy on 3 Nov 2026.