Study of the Correlation Between Specific Genes and Cognitive Dysfunction After Surgery - Full Text View

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)

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

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

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:

Abildstrom H, Christiansen M, Siersma VD, Rasmussen LS; ISPOCD2 Investigators. Apolipoprotein E genotype and cognitive dysfunction after noncardiac surgery. Anesthesiology. 2004 Oct;101(4):855-61.

Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. Erratum in: Lancet 1998 Jun 6;351(9117):1742.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Voigt Hansen M, Rasmussen LS, Jespersgaard C, Rosenberg J, Gogenur I. There is no association between the circadian clock gene HPER3 and cognitive dysfunction after noncardiac surgery. Anesth Analg. 2012 Aug;115(2):379-85. Epub 2012 Apr 27.

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 May 23, 2013