- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03899389
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
-
-
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.
|
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.
|
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.
|
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.
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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