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History of Changes for Study: NCT05645965
Association of Obesity and Cardiovascular Outcomes in Patients With Implantable Cardioverter-defibrillator (ICD) (Paradox)
Latest version (submitted July 26, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 2, 2022 None (earliest Version on record)
2 December 11, 2022 Study Description and Study Status
3 July 26, 2023 Study Status
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Study NCT05645965
Submitted Date:  December 2, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: AJOUIRB-EXP-2021-398-5
Brief Title: Association of Obesity and Cardiovascular Outcomes in Patients With Implantable Cardioverter-defibrillator (ICD) (Paradox)
Official Title: Association of Obesity and Cardiovascular Outcomes in Patients With Implantable Cardioverter-defibrillator (ICD) : a Korean Nationwide Cohort Study
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2022
Overall Status: Recruiting
Study Start: July 1, 2022
Primary Completion: June 30, 2023 [Anticipated]
Study Completion: June 30, 2023 [Anticipated]
First Submitted: December 2, 2022
First Submitted that
Met QC Criteria:
December 2, 2022
First Posted: December 12, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
December 2, 2022
Last Update Posted: December 12, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Ajou University School of Medicine
Responsible Party: Principal Investigator
Investigator: Kwang-No Lee
Official Title: Professor
Affiliation: Ajou University School of Medicine
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: In this study, we 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.
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.

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.

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]. We 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, we 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.

Open or close this module Conditions
Conditions: Implantable Defibrillator User
Arrhythmias, Cardiac
Obesity
Cardiovascular Morbidity
Keywords: implantable cardioverter-defibrillator (ICD)
obesity paradox
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Other
Biospecimen Retention:
Biospecimen Description:
Enrollment: 20000 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
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 Names:
  • Implantable cardioverter-defibrillator insertion
Open or close this module Outcome Measures
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
Open or close this module Eligibility
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.

Sampling Method: Non-Probability Sample
Minimum Age: 20 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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
Open or close this module Contacts/Locations
Central Contact Person: Kwang-No LEE
Telephone: +82-9286-1123
Email: knlee81@ajou.ac.kr
Central Contact Backup: Moon-Seung SOH
Telephone: +82-10-5386-7701
Email: mssoh7701@gmail.com
Study Officials: Kwang-No LEE
Study Chair
Ajou University School of Medicine
Locations: Korea, Republic of, Gyeong-gido
Ajou University School of Medicine
[Recruiting]
Suwon, Gyeong-gido, Korea, Republic of, 16499
Contact:Contact: Kwang-No LEE
Contact:Principal Investigator: Kwang-No LEE
Contact:Sub-Investigator: Moon-Seung SOH
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations: 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. PubMed 34333589
Echouffo-Tcheugui JB, Masoudi FA, Bao H, Curtis JP, Heidenreich PA, Fonarow GC. Body mass index and outcomes of cardiac resynchronization with implantable cardioverter-defibrillator therapy in older patients with heart failure. Eur J Heart Fail. 2019 Sep;21(9):1093-1102. doi: 10.1002/ejhf.1552. Epub 2019 Jul 29. PubMed 31359595
Samanta R, Narayan A, Pouliopoulos J, Kovoor P, Thiagalingam A. Influence of Body Mass Index on Recurrence of Ventricular Arrhythmia, Mortality in Defibrillator Recipients With Ischaemic Cardiomyopathy. Heart Lung Circ. 2020 Feb;29(2):254-261. doi: 10.1016/j.hlc.2018.12.018. Epub 2019 Jan 30. PubMed 30922553
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