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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02084030
Other study ID # DONG2014POCD
Secondary ID
Status Recruiting
Phase N/A
First received March 4, 2014
Last updated August 14, 2014
Start date March 2013
Est. completion date September 2014

Study information

Verified date August 2014
Source Xijing Hospital
Contact Hailong DONG, MD, PhD
Phone 86-2984775337
Email hldong6@hotmail.com
Is FDA regulated No
Health authority China: National Natural Science FoundationChina: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The aim of this study is to perform a whole-genome linkage analysis for identification of the susceptibility loci for POCD


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 60 Years to 75 Years
Eligibility Inclusion Criteria:

1. Age from 60 to 75 years old;

2. Schedule for on-pump cardiac surgery;

3. undergoing full intravenous anesthesia;

4. without hepatic, renal, pulmonary disease or full intravenous anesthesia surgery history;

5. Gave the informed consent.

Exclusion Criteria:

1. Emergency surgery;

2. A history of cerebrovascular disease;

3. The history of mental disease;

4. Long term use of sedative and antidepressant drugs;

5. Alcoholism;

6. serious vision, hearing impairment and inapprehensive language;

7. chromosomal abnormalities;

8. blood disease;

9. refused to sign the informed consent.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
China Xijing Hospital Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary single nucleotide polymorphisms(SNPs) of each patient about 10 minutes before anesthesia induction No
Secondary mini-mental state examination scale the cognitive function one day before surgery, 7 d after surgery No
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