- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05645926
Association of Obesity and Cardiovascular Outcomes in Myocardial Infarction (Paradox)
Association of Obesity and Cardiovascular Outcomes in Patients With Myocardial Infarction : a Korean Nationwide Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
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 newly diagnosed with MI and underwent revascularization (PCI or CABG) between January 2015 and December 2020. Patients aged <20 years, those who were already diagnosed with MI 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 diagnosis) 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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Gyeong-gido
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Suwon, Gyeong-gido, Korea, Republic of, 16499
- Ajou University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients newly diagnosed with MI and underwent revascularization (PCI or CABG) between January 2015 and December 2020.
Exclusion Criteria:
- Patients aged <20 years
- Patients diagnosed with MI before 2015
- Patients with cancer
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with MI who underwent revascularization during study period
Patients newly diagnosed with MI and underwent revascularization (PCI or CABG) during study period
|
Patients who underwent percutaneous coronary intervention (PCI), including percutaneous transluminal coronary angioplasty (PTCA), and coronary stent insertion
Other Names:
Patients who underwent coronary artery bypass grafting (CABG)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MACE
Time Frame: 5 years
|
Thromboembolism + Death + CV hospitalization
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Death
Time Frame: 5 years
|
Mortality
|
5 years
|
CV hospitalization
Time Frame: 5 years
|
Admission caused by Cardiovacular disease
|
5 years
|
Thromboembolism
Time Frame: 5 years
|
Recurrent myocardial infarction, Stroke
|
5 years
|
Collaborators and Investigators
Investigators
- Study Chair: Kwang-No LEE, Ajou University School of Medicine
Publications and helpful links
General Publications
- 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.
- Park SJ, Ha KH, Kim DJ. Body mass index and cardiovascular outcomes in patients with acute coronary syndrome by diabetes status: the obesity paradox in a Korean national cohort study. Cardiovasc Diabetol. 2020 Nov 10;19(1):191. doi: 10.1186/s12933-020-01170-w.
- Biswas S, Andrianopoulos N, Dinh D, Duffy SJ, Lefkovits J, Brennan A, Noaman S, Ajani A, Clark DJ, Freeman M, Oqueli E, Hiew C, Reid CM, Stub D, Chan W. Association of Body Mass Index and Extreme Obesity With Long-Term Outcomes Following Percutaneous Coronary Intervention. J Am Heart Assoc. 2019 Nov 5;8(21):e012860. doi: 10.1161/JAHA.119.012860. Epub 2019 Oct 25.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AJOUIRB-EXP-2021-398-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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