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Association of Obesity and Cardiovascular Outcomes in Patients With Implantable Cardioverter-defibrillator (ICD) (Paradox)

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ClinicalTrials.gov Identifier: NCT05645965
Recruitment Status : Recruiting
First Posted : December 12, 2022
Last Update Posted : July 27, 2023
Sponsor:
Information provided by (Responsible Party):
Kwang-No Lee, Ajou University School of Medicine

Study Description
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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 Implantable Cardioverter-defibrillator (ICD) insertion, using a nationwide population based cohort.

Condition or disease Intervention/treatment
Implantable Defibrillator User Arrhythmias, Cardiac Obesity Cardiovascular Morbidity Device: ICD insertion

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 implantable cardioverter-defibrillator (ICD) insertion between January 2015 and December 2020. Patients aged <20 years, those who were already taken ICD 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Association of Obesity and Cardiovascular Outcomes in Patients With Implantable Cardioverter-defibrillator (ICD) : a Korean Nationwide Cohort Study
Actual Study Start Date : July 1, 2022
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients who underwent implantable cardioverter-defibrillator (ICD) insertion during study period
Patients who underwent implantable cardioverter-defibrillator (ICD) insertion between January 2015 and December 2020
 Device: ICD insertion
Patients who underwent implantable cardioverter-defibrillator (ICD) insertion between January 2015 and December 2020
Other Name: Implantable cardioverter-defibrillator insertion


Outcome Measures
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Primary Outcome Measures :
  1. Composite of Outcomes [ Time Frame: 5 years ]
    Death + CV hospitalization + Fatal arrest event + Infective endocarditis


Secondary Outcome Measures :
  1. Death [ Time Frame: 5 years ]
    Mortality

  2. CV hospitalization [ Time Frame: 5 years ]
    Admission caused by Cardiovacular disease

  3. Fatal arrest event [ Time Frame: 5 years ]
    Event of cardiac arrest by ventricular tachycardia and fibrillation

  4. Infective endocarditis [ Time Frame: 5 years ]
    Diagnosed with infective endocarditis


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

We included patients who underwent implantable cardioverter-defibrillator (ICD) insertion between January 2015 and December 2020. Patients aged <20 years, those who were already taken ICD 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.

Criteria

Inclusion Criteria:

  • Patients who underwent implantable cardioverter-defibrillator (ICD) insertion between January 2015 and December 2020

Exclusion Criteria:

  • Patients aged <20 years
  • Patients already taken ICD insertion before 2015
  • Patients with cancer
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05645965


Contacts
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Contact: Kwang-No LEE +82-9286-1123 knlee81@ajou.ac.kr
Contact: Moon-Seung SOH +82-10-5386-7701 mssoh7701@gmail.com

Locations
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Korea, Republic of
Ajou University School of Medicine Recruiting
Suwon, Gyeong-gido, Korea, Republic of, 16499
Contact: Kwang-No LEE         
Principal Investigator: Kwang-No LEE         
Sub-Investigator: Moon-Seung SOH         
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
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Study Chair: Kwang-No LEE Ajou University School of Medicine
More Information
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Publications:

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Responsible Party: Kwang-No Lee, Professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT05645965    
Other Study ID Numbers: AJOUIRB-EXP-2021-398-5
First Posted: December 12, 2022    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kwang-No Lee, Ajou University School of Medicine:
implantable cardioverter-defibrillator (ICD)
obesity paradox
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Obesity
Overweight
Overnutrition
Nutrition Disorders
 Body Weight
Heart Diseases
Cardiovascular Diseases
Pathologic Processes