NCT03605121

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

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

Study Start

First participant enrolled

June 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

1.7 years

First QC Date

July 22, 2018

Last Update Submit

April 17, 2024

Conditions

Obesity, Abdominal

Keywords

waist circumferencebody mass indexcardiac surgerymortality

Outcome Measures

Primary Outcomes (1)

  • mortality

    mortality after cardiac surgery

    through study completion, average 3 years

Interventions

cardiac surgeryPROCEDURE

The relationship between body mass index or waist circumference and clinical outcome in patients undergoing cardiac surgery will be assessed

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Youn Joung Cho, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

July 22, 2018

First Posted

July 30, 2018

Study Start

June 1, 2018

Primary Completion

February 1, 2020

Study Completion

March 1, 2020

Last Updated

April 19, 2024

Record last verified: 2024-04

Locations

KR(1)