NCT05645978

Brief Summary

In this study, the investigators evaluated the association between various measures of adiposity \[BMI and waist circumference (WC)\] and clinical outcomes in Asian patients who underwent pacemaker insertion, using a nationwide population based cohort.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

2.3 years

First QC Date

December 2, 2022

Last Update Submit

July 26, 2023

Conditions

Pacemaker ComplicationArrhythmias, CardiacObesityCardiovascular Morbidity

Keywords

PacemakerObesity paradox

Outcome Measures

Primary Outcomes (1)

  • Composite of Outcomes

    Death + CV hospitalization + Fatal arrest event + Infective endocarditis

    5 years

Secondary Outcomes (4)

  • Death

    5 years

  • CV hospitalization

    5 years

  • Fatal arrest event

    5 years

  • Infective endocarditis

    5 years

Study Arms (1)

Patients who underwent pacemaker insertion during study period

Patients who underwent pacemaker insertion between January 2015 and December 2020

Device: Pacemaker insertion

Interventions

Pacemaker insertionDEVICE

Patients who underwent pacemaker insertion between January 2015 and December 2020

Also known as: Insertion of pacemaker
Patients who underwent pacemaker insertion during study period

Eligibility Criteria

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

We included patients who underwent pacemaker insertion between January 2015 and December 2020. Patients aged \<20 years, those who were already taken pacemaker insertion before 2015, and those with cancer were excluded from the analysis. The follow-up period was defined as the time from the index date (date of device procedure) to each outcome event, date of death, or end of the study period (December 31, 2020), whichever came first.

You may qualify if:

  • Patients who underwent pacemaker insertion between January 2015 and December 2020

You may not qualify if:

  • Patients aged \<20 years
  • Patients already taken pacemaker insertion before 2015
  • Patients with cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University School of Medicine

Suwon, Gyeonggi-do, 16499, South Korea

RECRUITING

Related Publications (3)

  • Kim MS, Kim WJ, Khera AV, Kim JY, Yon DK, Lee SW, Shin JI, Won HH. Association between adiposity and cardiovascular outcomes: an umbrella review and meta-analysis of observational and Mendelian randomization studies. Eur Heart J. 2021 Sep 7;42(34):3388-3403. doi: 10.1093/eurheartj/ehab454.

    PMID: 34333589BACKGROUND

  • Prasitlumkum N, Chokesuwattanaskul R, Kaewput W, Thongprayoon C, Bathini T, Boonpheng B, Vallabhajosyula S, Cheungpasitporn W, Jongnarangsin K. Utilization and in-hospital complications of catheter ablation for atrial fibrillation in patients with obesity and morbid obesity. Clin Cardiol. 2022 Apr;45(4):407-416. doi: 10.1002/clc.23795. Epub 2022 Feb 16.

    PMID: 35170775BACKGROUND

  • Seo J, Li W, Safiriyu I, Kharawala A, Nagraj S, Tahir A, Doundoulakis I, Koliastasis L, Rios S, Palaiodimos L, Kokkinidis DG. A Meta-Analysis on the Impact of High BMI in Patients Undergoing Transcatheter Aortic Valve Replacement. J Cardiovasc Dev Dis. 2022 Nov 9;9(11):386. doi: 10.3390/jcdd9110386.

    PMID: 36354785BACKGROUND

MeSH Terms

Conditions

Arrhythmias, CardiacObesity

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and Symptoms

Study Officials

  • Kwang-No LEE

    Ajou University School of Medicine

    STUDY CHAIR

Central Study Contacts

Kwang-No LEE

CONTACT

+82-9286-1123knlee81@ajou.ac.kr

Moon-Seung SOH

CONTACT

+82-10-5386-7701mssoh7701@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 2, 2022

First Posted

December 12, 2022

Study Start

July 1, 2022

Primary Completion

October 31, 2024

Study Completion

December 31, 2024

Last Updated

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)