Trimethylamine N-oxide in Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03418285
• Other study ID #: TMAO_STEMI
• Status: Completed
• Phase: N/A
• First received: January 25, 2018
• Last updated: January 31, 2018
• Start date: January 1, 2007
• Est. completion date: January 1, 2018

Study information

• Verified date: January 2018
• Source: Yokohama City University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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:

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yokohama City University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE	death, myocardial infarction, ischemic stroke, and unstable angina pectoris with coronary revascularization	6 years
Secondary	Coronary plaque progression	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.	10 months