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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date April 1, 2019
First Posted Date April 2, 2019
Last Update Posted Date April 4, 2019
Actual Study Start Date February 1, 2017
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 1, 2019)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Plasma TMAO (Trimethylamine N-oxide) as a Predictive Marker in Coronary Disease Patients
Official Title Plasma TMAO (Trimethylamine N-oxide) as a Predictive Marker in Coronary Disease Patients
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.

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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
plasma
Sampling Method Non-Probability Sample
Study Population Patients from the Pomeranian Cardiology Centers in Wejherowo
Condition Coronary Disease
Intervention Diagnostic Test: plasma samples collection
Trimethylamine N-oxide (TMAO) concentration will be determined in plasma samples
Study Groups/Cohorts
  • Acute Coronary Syndrome (ACS)
    Patients with STEMI or NSTEMI infarction, who were admitted to the hospital with chest pain.
    Intervention: Diagnostic Test: plasma samples collection
  • Stable Angina (SA)
    Patients with stable angina who were scheduled for conventional coronary angiography.
    Intervention: Diagnostic Test: plasma samples collection
  • Control Group (CON)
    Healthy control group responding by age and gender to examined groups.
    Intervention: Diagnostic Test: plasma samples collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 1, 2019)
600
Original Actual Enrollment Same as current
Actual Study Completion Date May 31, 2018
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • unconscious patient
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Poland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03899389
Other Study ID Numbers DSRiK/10/2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Robert Olek, Gdansk University of Physical Education and Sport
Study Sponsor Gdansk University of Physical Education and Sport
Collaborators Not Provided
Investigators
Principal Investigator: Robert A Olek, PhD University of Physical Education and Sport in Gdansk
PRS Account Gdansk University of Physical Education and Sport
Verification Date April 2019