NCT03903601

Brief Summary

The primary aim of the current research project is to answer the question, whether plasma trimethylamine N-oxide (TMAO) level may be used as a marker of ischemic changes in the brain. TMAO is associated with endothelial dysfunction, inflammation and oxidative stress. The hypothesis is that circulating TMAO level may predict leukoaraiosis (LA) and/or stroke. Secondary, the investigators would like to examine whether plasma TMAO concentration is related to cognitive impairment and determine whether choline consumption is associated with an incidence of LA severity and dementia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
2.7 years until next milestone

Study Start

First participant enrolled

December 30, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

July 20, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

April 1, 2019

Last Update Submit

July 19, 2021

Conditions

Vascular DiseasesLeukoaraiosisIschemia, Cerebral

Keywords

trimethylamine-N-oxidemagnetic resonance imagingcognitive functions

Outcome Measures

Primary Outcomes (2)

  • Brain Magnetic Resonance Imaging (MRI)

    Leukoaraiosis severity will be evaluated in MRI scans according to the Fazekas' scale. Will be grading scale for periventricular hyperintensities (PVH) and scale of deep white matter hyperintensities.

    before qualifying for the study, during the recruitment period

  • Trimethylamine-N-oxide (TMAO) blood concentration

    TMAO concentration determined by the ultra-performance liquid-chromatography tandem mass spectrometry (UPLC-MS/MS), marked in µmol/l.

    up to 4 weeks after brain MRI

Secondary Outcomes (3)

  • Brain-derived neurotrophic factor (BDNF)

    up to 4 weeks after brain MRI

  • Mini Mental State Examination (MMSE)

    up to 4 weeks after brain MRI

  • Trail Making Test (TMT)

    up to 4 weeks after brain MRI

Study Arms (2)

Ischemic changes

Patients with ischemic changes in the brain diagnosed by MRI

Diagnostic Test: Magnetic Resonance Imaging (MRI)Diagnostic Test: Blood samples collectionDiagnostic Test: Neuropsychological tests

No ischemic changes

Patients without ischemic changes in the brain diagnosed by MRI

Diagnostic Test: Magnetic Resonance Imaging (MRI)Diagnostic Test: Blood samples collectionDiagnostic Test: Neuropsychological tests

Interventions

Magnetic Resonance Imaging (MRI)DIAGNOSTIC_TEST

Magnetic Resonance Imaging (MRI) to diagnose ischemic changes in the brain.

Ischemic changesNo ischemic changes
Blood samples collectionDIAGNOSTIC_TEST

Trimethylamine N-oxide (TMAO) concentration, oxidative stress markers and endothelial dysfunction markers will be determined in blood samples.

Ischemic changesNo ischemic changes
Neuropsychological testsDIAGNOSTIC_TEST

Cognitive functions assessment

Ischemic changesNo ischemic changes

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from 7th Navy Hospital in Gdansk, which had a brain MRI performed within the past 4 weeks.

You may qualify if:

  • the ischemic changes in the brain (diagnosed by neurologist by MRI scans)

You may not qualify if:

  • no ischemic changes in the brain (diagnosed by neurologist by MRI scans)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Physical Education and Sport

Gdansk, Pomeranian Voivodeship, 80-336, Poland

Location

MeSH Terms

Conditions

Vascular DiseasesLeukoaraiosisBrain Ischemia

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Robert A Olek, PhD

    Gdansk University of Physical Education and Sport

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert A Olek, PhD

CONTACT

58 5547392robol@awf.gda.pl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 1, 2019

First Posted

April 4, 2019

Study Start

December 30, 2021

Primary Completion

April 30, 2022

Study Completion

May 1, 2022

Last Updated

July 20, 2021

Record last verified: 2021-02

Locations

PL(1)