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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

March 12, 2010
January 7, 2011
August 2010
January 2011   (final data collection date for primary outcome measure)
HPER3 genotype [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01088100 on ClinicalTrials.gov Archive Site
Post-operative morbidity [ Time Frame: ½ year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of the Correlation Between Specific Genes and Cognitive Dysfunction After Surgery
The Correlation Between Certain Clock-gene Genotypes and POCD (Post-operative Cognitive Dysfunction)

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood on filter paper

Non-Probability Sample

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.

  • Genotype
  • Cognitive Impairment
Genetic: Genotyping
Determination of 3 types of clock gene genotypes (HPER 4/4, 5/4, 5/5) on all blood samples
  • 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.
    Intervention: Genetic: Genotyping
  • 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.
    Intervention: Genetic: Genotyping

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
279
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01088100
MVH-01
No
Melissa Voigt Hansen, Herlev Hospital
Herlev Hospital
Not Provided
Principal Investigator: Melissa V Hansen, MD Herlev Hospital
Herlev Hospital
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP