Study of the Correlation Between Specific Genes and Cognitive Dysfunction After Surgery

This study has been completed.
Sponsor:
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01088100
First received: March 12, 2010
Last updated: January 7, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to determine whether a certain clock-gene (HPER3) with the 5/5 genotype carries a higher risk of post-operative cognitive dysfunction.


Condition Intervention
Genotype
Cognitive Impairment
Genetic: Genotyping

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: The Correlation Between Certain Clock-gene Genotypes and POCD (Post-operative Cognitive Dysfunction)

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • HPER3 genotype [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-operative morbidity [ Time Frame: ½ year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood on filter paper


Enrollment: 279
Study Start Date: August 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with POCD - cases
Out of the 976 patients included in the ISPOCD2 study (Abildstrom H, Christiansen M et al. Apolipoprotein E genotype and cognitive dysfunction after noncardiac surgery. Anesthesiology 2004;101:855-61) the 93 patients with POCD whose blood samples are stored will be included together with 2x93 controls (without POCD), who will be matched by type of surgery, age, education, ASA-score and sex.
Genetic: Genotyping
Determination of 3 types of clock gene genotypes (HPER 4/4, 5/4, 5/5) on all blood samples
Patients without POCD - controls
Out of the 976 patients included in the ISPOCD2 study (Abildstrom H, Christiansen M et al. Apolipoprotein E genotype and cognitive dysfunction after noncardiac surgery. Anesthesiology 2004;101:855-61) the 93 patients with POCD whose blood samples are stored will be included together with 2x93 controls (without POCD), who will be matched by type of surgery, age, education, ASA-score and sex.
Genetic: Genotyping
Determination of 3 types of clock gene genotypes (HPER 4/4, 5/4, 5/5) on all blood samples

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Out of the 976 patients included in the ISPOCD2 study (Abildstrom H, Christiansen M et al. Apolipoprotein E genotype and cognitive dysfunction after noncardiac surgery. Anesthesiology 2004;101:855-61)100 patients with POCD whose blood samples are stored will be included together with 100 controls (without POCD), who will be matched by type of surgery, age and sex.

Criteria

Inclusion Criteria:

  • patients undergoing non-cardiac and non-neurological surgery in either regional or general anesthesia

Exclusion Criteria:

  • daily use of major tranquilizers or antipsychotic medication
  • known disease of the CNS
  • score less than 24/30 points in MMSE
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088100

Locations
Denmark
Herlev Hospital - Gastro unit
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Investigators
Principal Investigator: Melissa V Hansen, MD Herlev Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Melissa Voigt Hansen, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01088100     History of Changes
Other Study ID Numbers: MVH-01
Study First Received: March 12, 2010
Last Updated: January 7, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Herlev Hospital:
POCD
clock-gene genotypes
HPER3

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 30, 2014