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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05645965
Other study ID # AJOUIRB-EXP-2021-398-5
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2022
Est. completion date December 31, 2024

Study information

Verified date July 2023
Source Ajou University School of Medicine
Contact Kwang-No LEE
Phone +82-9286-1123
Email knlee81@ajou.ac.kr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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Study Design


Intervention

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

Locations

Country Name City State
Korea, Republic of Ajou University School of Medicine Suwon Gyeong-gido

Sponsors (1)

Lead Sponsor Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Composite of Outcomes Death + CV hospitalization + Fatal arrest event + Infective endocarditis 5 years
Secondary Death Mortality 5 years
Secondary CV hospitalization Admission caused by Cardiovacular disease 5 years
Secondary Fatal arrest event Event of cardiac arrest by ventricular tachycardia and fibrillation 5 years
Secondary Infective endocarditis Diagnosed with infective endocarditis 5 years
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