NCT01088100

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
279

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 12, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 10, 2011

Status Verified

January 1, 2011

Enrollment Period

5 months

First QC Date

March 12, 2010

Last Update Submit

January 7, 2011

Conditions

GenotypeCognitive Impairment

Keywords

POCDclock-gene genotypesHPER3

Outcome Measures

Primary Outcomes (1)

  • HPER3 genotype

    3 months

Secondary Outcomes (1)

  • Post-operative morbidity

    ½ year

Study Arms (2)

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

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

Interventions

GenotypingGENETIC

Determination of 3 types of clock gene genotypes (HPER 4/4, 5/4, 5/5) on all blood samples

Patients with POCD - casesPatients without POCD - controls

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • daily use of major tranquilizers or antipsychotic medication
  • known disease of the CNS
  • score less than 24/30 points in MMSE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital - Gastro unit

Herlev, 2730, Denmark

Location

Related Publications (3)

  • 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. doi: 10.1097/00000542-200410000-00009.

    PMID: 15448517BACKGROUND

  • 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. doi: 10.1016/s0140-6736(97)07382-0.

    PMID: 9525362BACKGROUND

  • 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. doi: 10.1213/ANE.0b013e318253d6b3. Epub 2012 Apr 27.

    PMID: 22543063DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood on filter paper

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Genotype

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

  • Melissa V Hansen, MD

    Herlev Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 12, 2010

First Posted

March 17, 2010

Study Start

August 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

January 10, 2011

Record last verified: 2011-01

Locations

DK(1)