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

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ClinicalTrials.gov Identifier: NCT03899389
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Robert Olek, 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.


Condition or disease Intervention/treatment
Coronary Disease Diagnostic Test: plasma samples collection

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.

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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Plasma TMAO (Trimethylamine N-oxide) as a Predictive Marker in Coronary Disease Patients
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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).


Biospecimen Retention:   None Retained
plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients from the Pomeranian Cardiology Centers in Wejherowo
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • unconscious patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899389


Locations
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Poland
University of Physical Education and Sport
Gdansk, Pomorskie, Poland, 80-336
Sponsors and Collaborators
Gdansk University of Physical Education and Sport
Investigators
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Principal Investigator: Robert A Olek, PhD University of Physical Education and Sport in Gdansk

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Responsible Party: Robert Olek, Associate Professor, Gdansk University of Physical Education and Sport
ClinicalTrials.gov Identifier: NCT03899389     History of Changes
Other Study ID Numbers: DSRiK/10/2018
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robert Olek, Gdansk University of Physical Education and Sport:
trimethylamine-N-oxide

Additional relevant MeSH terms:
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Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases