Trimethylamine N-oxide in Myocardial Infarction

Completed

• Conditions: Myocardial Infarction

• Registration Number: NCT03418285
• Lead Sponsor: Yokohama City University Medical Center

Brief Summary

Trimethylamine-N-oxide (TMAO) is produced from the metabolism of gut microbiota and is reportedly pro-atherogenic and associated with cardiovascular events. The purpose of this study is to investigate the sequential change in TMAO levels by current optimal secondary prevention therapies in patients with ST-elevation acute myocardial infarction (STEMI) and the clinical impact of TMAO levels on the progression of atherosclerosis and subsequent cardiovascular events.

Detailed Description

This study includes patients with their first STEMI. The investigators measure plasma TMAO levels using the frozen plasma at the onset of STEMI and 10 months later (the chronic phase). To assess plaque progression, residual SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score and chronic-phase SYNTAX score are measured. After the chronic-phase assessment of TMAO and SYNTAX score, patients are followed for cardiovascular events including death, myocardial infarction, ischemic stroke, and unstable angina pectoris with coronary revascularization.

Study Timeline

• Study Start: 2007-01-01
• Status Verified: 2018-01
• Primary Completion: 2018-01-01
• Study Completion: 2018-01-01
• Study First Submitted: 2018-01-25
• Study First Submitted QC: 2018-01-25
• Last Update Submitted: 2018-01-31
• Study First Posted: 2018-02-01
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Patients who admitted to the Yokohama City University Medical Center with the diagnosis of their first STEMI and who underwent primary percutaneous coronary intervention within 12 hours after onset and received follow-up coronary angiogram 10 months after the index intervention.

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MACE	6 years	death, myocardial infarction, ischemic stroke, and unstable angina pectoris with coronary revascularization

Secondary Outcome Measures

Name	Time	Method
Coronary plaque progression	10 months	the highest tertile of change in SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score.; Higher SYNTAX score indicates more complicated coronary plaque. minimum 0, maximum 80.