NCT02084030

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 15, 2014

Status Verified

August 1, 2014

Enrollment Period

1.5 years

First QC Date

March 4, 2014

Last Update Submit

August 14, 2014

Conditions

Cardiac Surgery Patients

Keywords

cardiac surgeryPOCDGWASSusceptibility gene

Outcome Measures

Primary Outcomes (1)

  • single nucleotide polymorphisms(SNPs) of each patient

    about 10 minutes before anesthesia induction

Secondary Outcomes (1)

  • mini-mental state examination scale

    one day before surgery, 7 d after surgery

Study Arms (2)

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

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Old patient(\>60 y) who are schedule to receive of-pump cardiac surgery.

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • chromosomal abnormalities;
  • blood disease;
  • refused to sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Biospecimen

blood collected one day before surgery

Study Officials

  • Hailong Dong, MD,PhD

    Xijing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hailong DONG, MD, PhD

CONTACT

86-2984775337hldong6@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 11, 2014

Study Start

March 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

August 15, 2014

Record last verified: 2014-08

Locations

CN(1)