NCT05645926

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

2.3 years

First QC Date

December 2, 2022

Last Update Submit

July 26, 2023

Conditions

Obesity Associated DisorderMyocardial Infarction

Keywords

Obesity paradoxMyocardial infarction

Outcome Measures

Primary Outcomes (1)

  • MACE

    Thromboembolism + Death + CV hospitalization

    5 years

Secondary Outcomes (3)

  • Thromboembolism

    5 years

  • Death

    5 years

  • CV hospitalization

    5 years

Study Arms (1)

Patients with MI who underwent revascularization during study period

Patients newly diagnosed with MI and underwent revascularization (PCI or CABG) during study period

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

Interventions

Percutaneous coronary intervention (PCI)PROCEDURE

Patients who underwent percutaneous coronary intervention (PCI), including percutaneous transluminal coronary angioplasty (PTCA), and coronary stent insertion

Also known as: Coronary intervention therapy
Patients with MI who underwent revascularization during study period
Coronary artery bypass grafting (CABG)PROCEDURE

Patients who underwent coronary artery bypass grafting (CABG)

Also known as: Coronary graft surgery
Patients with MI who underwent revascularization during study period

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We 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.

You may qualify if:

  • Patients newly diagnosed with MI and underwent revascularization (PCI or CABG) between January 2015 and December 2020.

You may not qualify if:

  • Patients aged \<20 years
  • Patients diagnosed with MI before 2015
  • Patients with cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University School of Medicine

Suwon, Gyeonggi-do, 16499, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 33172464BACKGROUND

  • 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.

    PMID: 34333589BACKGROUND

  • 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.

    PMID: 31648578BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Percutaneous Coronary InterventionCoronary Artery Bypass

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresMyocardial RevascularizationCardiac Surgical ProceduresVascular GraftingThoracic Surgical Procedures

Study Officials

  • Kwang-No LEE

    Ajou University School of Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 2, 2022

First Posted

December 12, 2022

Study Start

July 1, 2022

Primary Completion

October 31, 2024

Study Completion

December 31, 2024

Last Updated

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)