Aneurysm, DissectingACS-MOON-1NCT02236923
Study of the Influence of the Moon and Seasons On Outcomes Following Surgery To Repair Ascending Aortic Dissection
An observational study of Aneurysm, Dissecting and Aortic Aneurysm, run by 22EON at 1 site in United Kingdom.
Trial summary
That the full-moon stage of the lunar cycle is associated with reduced mortality and shorter length of stay in patients undergoing repair of aortic dissection, after adjusting for seasonal effects, demographics and cardiovascular risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm, Dissecting, Aortic Aneurysm
- How many people
- 2,684 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 1998to Mar 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All acute ascending aortic dissection repair procedures recorded in the United Kingdom's National Adult Cardiac Surgery Audit.
Who may be able to join
- acute dissection specified in aortic pathology
Who cannot join
- missing data in the demographic covariates (age, sex)
- missing data in the medical history (hypertension, diabetes, renal failure)
- missing surgical procedure date
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
National Institute for Cardiovascular Outcomes Research
London, W1T 7HA
About this study
Official title: The Influence of Lunar Cycle On Hospital Outcomes Following Ascending Aortic Dissection Repair
That the full-moon stage of the lunar cycle is associated with reduced mortality and shorter length of stay in patients undergoing repair of aortic dissection, after adjusting for seasonal effects, demographics and cardiovascular risk factors.
Read the detailed description
The primary objective of this study is to determine whether the findings of Shuhaiber et al. [2013] (see citations) may be confirmed using national audit data from the United Kingdom.
A cohort of all acute ascending aortic dissection repair surgeries will be extracted from the National Adult Cardiac Surgery Audit (NACSA) database. The current dataset version 4.12, available for download from the website of the National Institute for Cardiovascular Outcomes Research (see links), contains 168 fields that detail pre-operative patient characteristics, operative details and post-operative outcomes. The dataset is revised intermittently to meet the requirements of users and to respond to changes in the management of adult cardiac surgery; however, the fields to be analysed in this study have not been subject to any documented revisions. The extracted data are to be cleaned using version 9.9 of the NACSA cleaning algorithm.
Seasons are to be coded in the same way as in the published study: autumn (September 21 through December 20), winter (December 21 through March 21), spring (March 22 through June 21) and summer (June 22 through September 20).
Three definitions are to be used for the phases of the moon. The first definition mirrors that employed in the motivating work: each lunar cycle from new moon to new moon is to be split into four parts and labelled "New", "Waxing", "Full" and "Waning". The second definition centers each of those four labels around the named event: i.e., the "New" period is to be centered around the new moon event itself, instead of starting on the day of a new moon as in the first definition. The third definition will split the lunar cycle into 8 event-centred periods, called "New", "Waxing crescent", "First quarter", "Waxing gibbous", "Full", "Waning gibbous", "Last quarter" and "Waning crescent".
There is no need to explore the individual univariate relationships of predictors to outcomes in this work, given its limited purpose to confirm the earlier multivariate findings. The relationship between the environmental factors (seasons and the lunar cycle) and in-hospital mortality will be examined using multivariate logistic regression, controlling for demographic and mortality risk factors. The specific variables that can be included in common with the earlier work are age, sex, hypertension, diabetes, renal failure, and an indicator of weekend admission. The national audit does not include information on dyslipidaemia, but it is felt that its exclusion from our model will not effect the comparability of our work to the earlier study because none of the earlier published models showed any effect of dyslipidaemia on surgical outcomes. The relationship of the environmental factors to Length of stay (LOS) in survivors will be examined using a multivariate linear regression that includes the same risk factors as in the mortality model. As in the published study, LOS will be transformed to the natural logarithmic scale prior to analysis.
We will run all analyses with and without a European system for cardiac operative risk evaluation score (EuroSCORE) II risk adjustment. The EuroSCORE II was developed specifically to adjust for risk of in-hospital mortality. It will be employed here despite its absence from the published models to ensure that risk adjustment prior to estimation of the contributions of the environmental factors will be as thorough as reasonably possible.
All analyses will be performed using R version 3.1.0. Environmental factors will be calculated using the lunar package available from the CRAN software repository.
- Conditions
- Aneurysm, Dissecting, Aortic Aneurysm
- Keywords
- cardiovascular, surgery, ascending aorta, aortic dissection
- Medical subject headings
- Aortic Dissection, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Single procedure | Group A consists of patients recorded as having only had an ascending aortic dissection repair procedure. | |
| Group B: Multiple procedures | Group B consists of patients who had an ascending aortic dissection repair procedure together with any other surgical intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause in-hospital mortality
Measured: During hospital stay, an expected average of 8 days
Length of stay in hospital among survivors to discharge
Measured: During hospital stay, an expected average of 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startJan 1998
- Primary completionDec 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aneurysm, DissectingStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,684 participants (actual)
Sponsor and investigators
- Lead sponsor
- 22EON
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute for Cardiovascular Outcomes Research
- Responsible party
- Sponsor
- Investigators
- Emmanuel Lazaridis, PhD, LLB, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236923
- Sponsor's protocol ID
- NICOR-14-ACS-24
- Acronym
- ACS-MOON-1
- Status last verified
- Sep 2014
- First submitted
- 8 Sep 2014
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Shuhaiber JH, Fava JL, Shin T, Dobrilovic N, Ehsan A, Bert A, Sellke F. The influence of seasons and lunar cycle on hospital outcomes following ascending aortic dissection repair. Interact Cardiovasc Thorac Surg. 2013 Nov;17(5):818-22. doi: 10.1093/icvts/ivt299. Epub 2013 Jul 9.
PubMed 23838340
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Lunar Cycle On Hospital Outcomes Following Ascending Aortic Dissection Repair
- ClinicalTrials.gov ID
- NCT02236923
- Acronym / sponsor ID
- ACS-MOON-1 / NICOR-14-ACS-24
- Conditions
- Aneurysm, Dissecting, Aortic Aneurysm
- Keywords
- cardiovascular, surgery, ascending aorta, aortic dissection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,684 participants (actual)
- Lead sponsor
- 22EONIndustry (pharma, biotech, devices)
- Collaborators
- National Institute for Cardiovascular Outcomes Research
- Study start
- Jan 1998
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 11 Sep 2014 (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.
That the full-moon stage of the lunar cycle is associated with reduced mortality and shorter length of stay in patients undergoing repair of aortic dissection, after adjusting for seasonal effects, demographics and cardiovascular risk factors.
Detailed description
The primary objective of this study is to determine whether the findings of Shuhaiber et al. [2013] (see citations) may be confirmed using national audit data from the United Kingdom.
A cohort of all acute ascending aortic dissection repair surgeries will be extracted from the National Adult Cardiac Surgery Audit (NACSA) database. The current dataset version 4.12, available for download from the website of the National Institute for Cardiovascular Outcomes Research (see links), contains 168 fields that detail pre-operative patient characteristics, operative details and post-operative outcomes. The dataset is revised intermittently to meet the requirements of users and to respond to changes in the management of adult cardiac surgery; however, the fields to be analysed in this study have not been subject to any documented revisions. The extracted data are to be cleaned using version 9.9 of the NACSA cleaning algorithm.
Seasons are to be coded in the same way as in the published study: autumn (September 21 through December 20), winter (December 21 through March 21), spring (March 22 through June 21) and summer (June 22 through September 20).
Three definitions are to be used for the phases of the moon. The first definition mirrors that employed in the motivating work: each lunar cycle from new moon to new moon is to be split into four parts and labelled "New", "Waxing", "Full" and "Waning". The second definition centers each of those four labels around the named event: i.e., the "New" period is to be centered around the new moon event itself, instead of starting on the day of a new moon as in the first definition. The third definition will split the lunar cycle into 8 event-centred periods, called "New", "Waxing crescent", "First quarter", "Waxing gibbous", "Full", "Waning gibbous", "Last quarter" and "Waning crescent".
There is no need to explore the individual univariate relationships of predictors to outcomes in this work, given its limited purpose to confirm the earlier multivariate findings. The relationship between the environmental factors (seasons and the lunar cycle) and in-hospital mortality will be examined using multivariate logistic regression, controlling for demographic and mortality risk factors. The specific variables that can be included in common with the earlier work are age, sex, hypertension, diabetes, renal failure, and an indicator of weekend admission. The national audit does not include information on dyslipidaemia, but it is felt that its exclusion from our model will not effect the comparability of our work to the earlier study because none of the earlier published models showed any effect of dyslipidaemia on surgical outcomes. The relationship of the environmental factors to Length of stay (LOS) in survivors will be examined using a multivariate linear regression that includes the same risk factors as in the mortality model. As in the published study, LOS will be transformed to the natural logarithmic scale prior to analysis.
We will run all analyses with and without a European system for cardiac operative risk evaluation score (EuroSCORE) II risk adjustment. The EuroSCORE II was developed specifically to adjust for risk of in-hospital mortality. It will be employed here despite its absence from the published models to ensure that risk adjustment prior to estimation of the contributions of the environmental factors will be as thorough as reasonably possible.
All analyses will be performed using R version 3.1.0. Environmental factors will be calculated using the lunar package available from the CRAN software repository.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Single procedure | – | –Group A consists of patients recorded as having only had an ascending aortic dissection repair procedure. |
| Group B: Multiple procedures | – | –Group B consists of patients who had an ascending aortic dissection repair procedure together with any other surgical intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All acute ascending aortic dissection repair procedures recorded in the United Kingdom's National Adult Cardiac Surgery Audit.
Key inclusion criteria (1 listed)
- acute dissection specified in aortic pathology
Key exclusion criteria (3 listed)
- missing data in the demographic covariates (age, sex)
- missing data in the medical history (hypertension, diabetes, renal failure)
- missing surgical procedure date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All cause in-hospital mortality
Time frame: During hospital stay, an expected average of 8 days
Length of stay in hospital among survivors to discharge
Time frame: During hospital stay, an expected average of 18 days
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 11 Sep 2014.
- Background: PubMed 23838340Shuhaiber JH, Fava JL, Shin T, Dobrilovic N, Ehsan A, Bert A, Sellke F. The influence of seasons and lunar cycle on hospital outcomes following ascending aortic dissection repair. Interact Cardiovasc Thorac Surg. 2013 Nov;17(5):818-22. doi: 10.1093/icvts/ivt299. Epub 2013 Jul 9.
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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.
Emmanuel Lazaridis, PhD, LLB principal investigator
University College, London
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 Aneurysm, Dissecting and Aortic Aneurysm, run by 22EON at 1 site in United Kingdom.
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 11 Sep 2014. 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 United Kingdom. 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?
All cause in-hospital mortality (time frame: During hospital stay, an expected average of 8 days). The study lists 2 primary outcomes in all. 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 NCT02236923, which also lists 1 linked publication.
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 11 Sep 2014.