GenotypeNCT01088100
Study of the Correlation Between Specific Genes and Cognitive Dysfunction After Surgery
An observational study of Genotype and Cognitive Impairment, run by Herlev Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Genotype, Cognitive Impairment
- What is being tested?
- Genotyping
- How many people
- 279 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2010to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients undergoing non-cardiac and non-neurological surgery in either regional or general anesthesia
Who cannot join
- daily use of major tranquilizers or antipsychotic medication
- known disease of the CNS
- score less than 24/30 points in MMSE
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Genotype, Cognitive Impairment
- Being tested
- Genotyping
- Keywords
- POCD, clock-gene genotypes, HPER3
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenotypingGenetic
Determination of 3 types of clock gene genotypes (HPER 4/4, 5/4, 5/5) on all blood samples
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Genetic: Genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPER3 genotype
Measured: 3 months
Secondary outcomes (1)
Post-operative morbidity
Measured: ½ year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GenotypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Melissa V Hansen, MD, Principal investigator, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088100
- Sponsor's protocol ID
- MVH-01
- Status last verified
- Jan 2011
- First submitted
- 12 Mar 2010
- Last updated
- 10 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1097/00000542-200410000-00009.
PubMed 15448517Moller 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.
PubMed 9525362Voigt 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.
PubMed 22543063
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Certain Clock-gene Genotypes and POCD (Post-operative Cognitive Dysfunction)
- ClinicalTrials.gov ID
- NCT01088100
- Acronym / sponsor ID
- MVH-01
- Conditions
- Genotype, Cognitive Impairment
- Keywords
- POCD, clock-gene genotypes, HPER3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 17 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with POCD - cases | – | Genetic: GenotypingOut 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. |
| Patients without POCD - controls | – | Genetic: GenotypingOut 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients undergoing non-cardiac and non-neurological surgery in either regional or general anesthesia
Key exclusion criteria (3 listed)
- daily use of major tranquilizers or antipsychotic medication
- known disease of the CNS
- score less than 24/30 points in MMSE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenotypingDetermination of 3 types of clock gene genotypes (HPER 4/4, 5/4, 5/5) on all blood samples | Genetic | Patients with POCD - cases, Patients without POCD - controls |
Primary outcome
HPER3 genotype
Time frame: 3 months
1 secondary outcome
Post-operative morbidity
Time frame: ½ year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2011.
- Background: PubMed 15448517Abildstrom 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.
- Background: PubMed 9525362Moller 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.
- Derived from this study: PubMed 22543063Voigt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa V Hansen, MD principal investigator
Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genotype and Cognitive Impairment, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPER3 genotype (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01088100, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2011.