Trimethylamine N-oxide in Myocardial Infarction

Microbiota-derived Trimethylamine N-oxide as Residual Risk After ST-elevation Myocardial Infarction

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03418285

Enrollment

112

Registered

2018-02-01

Start date

2007-01-01

Completion date

2018-01-01

Last updated

2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
MACE	6 years	death, myocardial infarction, ischemic stroke, and unstable angina pectoris with coronary revascularization

Secondary

Measure	Time frame	Description
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.

Outcome results