Obesity Clinical Trial
— ParadoxOfficial title:
Association of Obesity and Cardiovascular Outcomes in Patients With Implantable Cardioverter-defibrillator (ICD) : a Korean Nationwide Cohort Study
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.
Status | Recruiting |
Enrollment | 20000 |
Est. completion date | December 31, 2024 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Ajou University School of Medicine | Suwon | Gyeong-gido |
Lead Sponsor | Collaborator |
---|---|
Ajou University School of Medicine |
Korea, Republic of,
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
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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