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Completed

NCT Number: NCT03418285

Trimethylamine N-oxide in Myocardial Infarction

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. MACE

    Time frame: 6 years

    death, myocardial infarction, ischemic stroke, and unstable angina pectoris with coronary revascularization

Secondary outcomes

  1. Coronary plaque progression

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yokohama City University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2018
Study completion
2018
First posted
Feb 1, 2018
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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