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Association of Obesity and Cardiovascular Outcomes in Patients With Pacemaker

Association of Obesity and Cardiovascular Outcomes in Patients With Pacemaker : a Korean Nationwide Cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05645978
Acronym
Paradox
Enrollment
20000
Registered
2022-12-12
Start date
2022-07-01
Completion date
2024-12-31
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmias, Cardiac, Cardiovascular Morbidity, Obesity, Pacemaker Complication

Keywords

Pacemaker, Obesity paradox

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.

Detailed description

This retrospective nationwide cohort study used administrative claims data from the Korean National Health Insurance Service (NHIS) and the combined health check-up database of the National Health Insurance Corporation between 2013 and 2020. The investigators 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. Patients' demographic data, comorbidities, concomitant medications, and income level were collected from the Korean NHIS database. The recent health check-up data from the index date was also ascertained, including height, weight, waist circumference, blood pressure, health surveys, and laboratory exam. Health survey included family history, smoking history, alcohol history, and the level of individual physical activity. According to BMI following the World Health Organization recommendation for Asian population, study patients were categorized into 5 groups: underweight, \<18.5 kg/m2; normal range, 18.5 to \<23 kg/m2; overweight, 23 to \<25 kg/m2; obese I, 25 to \<30 kg/m2; and obese II, ≥30 kg/m2\[4\]. The investigators defined the proportion of medical use by calculating formula with the recuperation cost and the number of the visit to hospitals. During the follow-up period, the investigators assessed 3 clinical outcomes, including all-cause death, cardiovascular hospitalization and the recurrence rate. Clinical outcomes were mainly defined by the the International Classification of Diseases, 10th revision (ICD-10). Patients were censored at the clinical outcomes or the end of the study period (December 31, 2020), whichever came first. All categorical variables are presented as frequencies and percentages. Normally distributed data were presented as mean ± standard deviation, whereas nonparametric data are presented as median and interquartile range by BMI. Cox proportional hazard regression analyses were performed to identify the association of BMI with the primary and secondary outcomes, calculating hazard ratio (HR) and 95% confidence interval (CI) and adjusting for the following potential confounders: sex, age, systolic blood pressure, fasting glucose level, total cholesterol level, alcohol consumption, smoking status, physical activity, household income, use of antihypertensive agents, use of statins, use of antiplatelet agents, previous history of MI, previous history of stroke, and index year. All analyses were conducted using R-statistics.

Interventions

DEVICEPacemaker insertion

Patients who underwent pacemaker insertion between January 2015 and December 2020

Sponsors

Ajou University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Composite of Outcomes5 yearsDeath + CV hospitalization + Fatal arrest event + Infective endocarditis

Secondary

MeasureTime frameDescription
Death5 yearsMortality
CV hospitalization5 yearsAdmission caused by Cardiovacular disease
Fatal arrest event5 yearsEvent of cardiac arrest by ventricular tachycardia and fibrillation
Infective endocarditis5 yearsDiagnosed with infective endocarditis

Countries

South Korea

Contacts

Primary ContactKwang-No LEE
knlee81@ajou.ac.kr+82-9286-1123
Backup ContactMoon-Seung SOH
mssoh7701@gmail.com+82-10-5386-7701

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026