Waist Circumference in Cardiac Surgery | NCT03605121

Studies
Waist Circumference in Cardiac Surgery

NCT03605121

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Apr 19, 2024Actual

Enrollment

5,000Actual

Phase

Not provided

Conditions

Obesity, Abdominal

Interventions

cardiac surgery

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Actual

Primary Completion Date

Feb 1, 2020Actual

Completion Date

Mar 1, 2020Actual

First Submitted Date

Jul 22, 2018

First Submission Date that Met QC Criteria

Jul 22, 2018

First Posted Date

Jul 30, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2024

Last Update Posted Date

Apr 19, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Youn Joung Cho, MD, PhD, Clinical assistant professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cardiac surgery	Procedure	The relationship between body mass index or waist circumference and clinical outcome in patients undergoing cardiac surgery will be assessed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality	mortality after cardiac surgery	through study completion, average 3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing cardiac surgery between 2004 and 2016 at Seoul National University Hospital

Exclusion Criteria:

Patients without information on height, weight, or waist circumference from abdominal computed tomography

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients undergoing cardiac surgery between 2004 and 2017 at Seoul National University Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Youn Joung Cho, MD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		03080	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D056128	Obesity, Abdominal

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006348	Cardiac Surgical Procedures

Ancestor Terms

ID	Term
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019616	Thoracic Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided