Association of Obesity and Cardiovascular Outcomes in Myocardial Infarction

Active, not recruiting

Conditions: Myocardial Infarction
Obesity Associated Disorder

Interventions: Procedure: Percutaneous coronary intervention (PCI)
Procedure: Coronary artery bypass grafting (CABG)

Registration Number: NCT05645926

Lead Sponsor: Ajou University School of Medicine

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 with Myocardial Infarction who underwent percutaneous coronary intervention or bypass surgery, 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.

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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 60000

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with MI who underwent revascularization during study period	Coronary artery bypass grafting (CABG)	Patients newly diagnosed with MI and underwent revascularization (PCI or CABG) during study period
Patients with MI who underwent revascularization during study period	Percutaneous coronary intervention (PCI)	Patients newly diagnosed with MI and underwent revascularization (PCI or CABG) during study period

Primary Outcome Measures

Name	Time	Method
MACE	5 years	Thromboembolism + Death + CV hospitalization

Secondary Outcome Measures

Name	Time	Method
Death	5 years	Mortality
Thromboembolism	5 years	Recurrent myocardial infarction, Stroke
CV hospitalization	5 years	Admission caused by Cardiovacular disease

Trial Locations

Locations (1): Ajou University School of Medicine
🇰🇷
Suwon, Gyeong-gido, Korea, Republic of