Coronary DiseaseNCT03899389
Plasma TMAO (Trimethylamine N-oxide) as a Predictive Marker in Coronary Disease Patients
An observational study of Coronary Disease, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Coronary Disease
- What is being tested?
- plasma samples collection
- How many people
- 600 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2017to 31 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients from the Pomeranian Cardiology Centers in Wejherowo
Who may be able to join
- diagnosed stable angina (SA) or acute coronary syndrome (ACS) and planned coronography
Who cannot join
- unconscious patient
Trial locations and contacts
1 site in 1 country.
Poland1 site
University of Physical Education and Sport
Gdansk, Pomeranian Voivodeship, 80-336
About this study
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.
Read the 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.
- Conditions
- Coronary Disease
- Being tested
- plasma samples collection
- Keywords
- trimethylamine-N-oxide
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasma samples collectionDiagnostic test
Trimethylamine N-oxide (TMAO) concentration will be determined in plasma samples
| Study group | Role | What they receive |
|---|---|---|
| Acute Coronary Syndrome (ACS) | Patients with STEMI or NSTEMI infarction, who were admitted to the hospital with chest pain. Receives: Diagnostic Test: plasma samples collection | |
| Stable Angina (SA) | Patients with stable angina who were scheduled for conventional coronary angiography. Receives: Diagnostic Test: plasma samples collection | |
| Control Group (CON) | Healthy control group responding by age and gender to examined groups. Receives: Diagnostic Test: plasma samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trimethylamine-N-oxidec(TMAO) blood concentration
TMAO concentration determined by the ultra-performance liquid-chromatography tandem mass spektrometry (UPLC-MS/MS).
Measured: Immediately before coronography.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Feb 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gdansk University of Physical Education and Sport
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Olek, Gdansk University of Physical Education and Sport
- Investigators
- Robert A Olek, PhD, Principal investigator, University of Physical Education and Sport in Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899389
- Sponsor's protocol ID
- DSRiK/10/2018
- Status last verified
- Apr 2019
- First submitted
- 1 Apr 2019
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma TMAO (Trimethylamine N-oxide) as a Predictive Marker in Coronary Disease Patients
- ClinicalTrials.gov ID
- NCT03899389
- Acronym / sponsor ID
- DSRiK/10/2018
- Conditions
- Coronary Disease
- Keywords
- trimethylamine-N-oxide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Gdansk University of Physical Education and SportUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute Coronary Syndrome (ACS) | – | Diagnostic Test: plasma samples collectionPatients with STEMI or NSTEMI infarction, who were admitted to the hospital with chest pain. |
| Stable Angina (SA) | – | Diagnostic Test: plasma samples collectionPatients with stable angina who were scheduled for conventional coronary angiography. |
| Control Group (CON) | – | Diagnostic Test: plasma samples collectionHealthy control group responding by age and gender to examined groups. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from the Pomeranian Cardiology Centers in Wejherowo
Key inclusion criteria (1 listed)
- diagnosed stable angina (SA) or acute coronary syndrome (ACS) and planned coronography
Key exclusion criteria (1 listed)
- unconscious patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plasma samples collectionTrimethylamine N-oxide (TMAO) concentration will be determined in plasma samples | Diagnostic test | Acute Coronary Syndrome (ACS), Control Group (CON), Stable Angina (SA) |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert A Olek, PhD principal investigator
University of Physical Education and Sport in Gdansk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trimethylamine-N-oxidec(TMAO) blood concentration (time frame: Immediately before coronography.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.