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

April 2, 2019 updated by: Robert Olek, Gdansk University of Physical Education and Sport

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-336
        • University of Physical Education and Sport

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from the Pomeranian Cardiology Centers in Wejherowo

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • unconscious patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute Coronary Syndrome (ACS)
Patients with STEMI or NSTEMI infarction, who were admitted to the hospital with chest pain.
Diagnostic test: plasma samples collection
Trimethylamine N-oxide (TMAO) concentration will be determined in plasma samples
Stable Angina (SA)
Patients with stable angina who were scheduled for conventional coronary angiography.
Diagnostic test: plasma samples collection
Trimethylamine N-oxide (TMAO) concentration will be determined in plasma samples
Control Group (CON)
Healthy control group responding by age and gender to examined groups.
Diagnostic test: plasma samples collection
Trimethylamine N-oxide (TMAO) concentration will be determined in plasma samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trimethylamine-N-oxidec(TMAO) blood concentration
Time Frame: Immediately before coronography.
TMAO concentration determined by the ultra-performance liquid-chromatography tandem mass spektrometry (UPLC-MS/MS).
Immediately before coronography.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gdansk University of Physical Education and Sport

Investigators

  • Principal Investigator: Robert A Olek, PhD, University of Physical Education and Sport in Gdansk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

May 31, 2018

Study Completion (Actual)

May 31, 2018

Study Registration Dates

First Submitted

April 1, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSRiK/10/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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