Obesity, AbdominalNCT03605121
Waist Circumference in Cardiac Surgery
An observational study of Obesity, Abdominal, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Metabolic syndrome including increased body mass index or waist circumference is known to be a risk factor of cardiovascular disease. However, the relationship between body mass index or waist circumference and clinical outcome after cardiac surgery has not been fully elucidated. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Obesity, Abdominal
- What is being tested?
- cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2018to 1 Mar 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing cardiac surgery between 2004 and 2017 at Seoul National University Hospital
Who may be able to join
- Patients undergoing cardiac surgery between 2004 and 2016 at Seoul National University Hospital
Who cannot join
- Patients without information on height, weight, or waist circumference from abdominal computed tomography
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Waist Circumference or BMI and Clinical Outcome in Cardiac Surgery
Metabolic syndrome including increased body mass index or waist circumference is known to be a risk factor of cardiovascular disease. However, the relationship between body mass index or waist circumference and clinical outcome after cardiac surgery has not been fully elucidated.
Read the detailed description
Along with body mass index, which is determined with height and weight, waist circumference reflects abdominal obesity and may increase cardio-metabolic risk and all-cause morbidity/mortality. In this observational study, we will review the electronic medical records of patients underwent cardiac surgery and assess their waist circumference, measured on preoperative computed tomography, as well as body mass index. The relationship between body mass index or waist circumference and mortality after cardiac surgery will be analysed.
- Conditions
- Obesity, Abdominal
- Being tested
- cardiac surgery
- Keywords
- waist circumference, body mass index, cardiac surgery, mortality
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac surgeryProcedure or surgery
The relationship between body mass index or waist circumference and clinical outcome in patients undergoing cardiac surgery will be assessed
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
mortality after cardiac surgery
Measured: through study completion, average 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start1 Jun 2018
- Primary completion1 Feb 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youn Joung Cho, MD, PhD, Seoul National University Hospital
- Investigators
- Youn Joung Cho, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605121
- Sponsor's protocol ID
- WC_cardiac surgery
- Status last verified
- Apr 2024
- First submitted
- 22 Jul 2018
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Waist Circumference or BMI and Clinical Outcome in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03605121
- Acronym / sponsor ID
- WC_cardiac surgery
- Conditions
- Obesity, Abdominal
- Keywords
- waist circumference, body mass index, cardiac surgery, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 30 Jul 2018 (actual)
- 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.
Metabolic syndrome including increased body mass index or waist circumference is known to be a risk factor of cardiovascular disease. However, the relationship between body mass index or waist circumference and clinical outcome after cardiac surgery has not been fully elucidated.
Detailed description
Along with body mass index, which is determined with height and weight, waist circumference reflects abdominal obesity and may increase cardio-metabolic risk and all-cause morbidity/mortality. In this observational study, we will review the electronic medical records of patients underwent cardiac surgery and assess their waist circumference, measured on preoperative computed tomography, as well as body mass index. The relationship between body mass index or waist circumference and mortality after cardiac surgery will be analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing cardiac surgery between 2004 and 2017 at Seoul National University Hospital
Key inclusion criteria (1 listed)
- Patients undergoing cardiac surgery between 2004 and 2016 at Seoul National University Hospital
Key exclusion criteria (1 listed)
- Patients without information on height, weight, or waist circumference from abdominal computed tomography
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 |
|---|---|---|
| cardiac surgeryThe relationship between body mass index or waist circumference and clinical outcome in patients undergoing cardiac surgery will be assessed | Procedure or surgery | – |
Primary outcome
mortality
Time frame: through study completion, average 3 years
mortality after cardiac surgery
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 19 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Youn Joung Cho, MD principal investigator
Seoul National University 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 Obesity, Abdominal, run by Seoul National University Hospital at 1 site in South Korea.
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 1 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 19 Apr 2024. 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 South Korea. 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?
mortality (time frame: through study completion, average 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2024.