Plasma TMAO (Trimethylamine N-oxide) as a Predictive Marker in Coronary Disease Patients

Completed

• Conditions: Coronary Disease
• Interventions: Diagnostic Test: plasma samples collection

• Registration Number: NCT03899389
• Lead Sponsor: Gdansk University of Physical Education and Sport

Brief Summary

The primary aim of the current research project is to determine whether the TMAO concentration in the blood can serve as a prognostic indicator of myocardial infarction.

The hypothesis is that in patients with recent myocardial infarction, TMAO concentration in blood is higher than in patients undergoing scheduled coronarography.

Detailed Description

To the study will be included volunteers - patients with stable angina (SA), who were scheduled for conventional coronary angiography, and patients with acute coronary syndrome (ACS) who were admitted to the hospital with chest pain and undergoing coronography surgery. Blood samples will be taken from volunteers once - before the coronography surgery by qualified medical personnel.

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Status Verified: 2019-04
• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-02
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• diagnosed stable angina (SA) or acute coronary syndrome (ACS) and planned coronography

Exclusion Criteria

• unconscious patient

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute Coronary Syndrome (ACS)	plasma samples collection	Patients with STEMI or NSTEMI infarction, who were admitted to the hospital with chest pain.
Stable Angina (SA)	plasma samples collection	Patients with stable angina who were scheduled for conventional coronary angiography.
Control Group (CON)	plasma samples collection	Healthy control group responding by age and gender to examined groups.

Primary Outcome Measures

Name	Time	Method
Trimethylamine-N-oxidec(TMAO) blood concentration	Immediately before coronography.	TMAO concentration determined by the ultra-performance liquid-chromatography tandem mass spektrometry (UPLC-MS/MS).

Trial Locations

Locations (1)

University of Physical Education and Sport; 🇵🇱 Gdansk, Pomorskie, Poland