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NCT03899389 Clinical Trial

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

Coronary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03899389
Other study ID # DSRiK/10/2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2017
Est. completion date May 31, 2018

Study information
Verified date April 2019
Source Gdansk University of Physical Education and Sport
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date May 31, 2018
Est. primary completion date May 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- unconscious patient

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• plasma samples collection
Trimethylamine N-oxide (TMAO) concentration will be determined in plasma samples

Locations
Country Name City State
Poland University of Physical Education and Sport Gdansk Pomorskie

Sponsors (1)
Lead Sponsor Collaborator
Gdansk University of Physical Education and Sport

Country where clinical trial is conducted

Poland, 

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