Vascular Diseases Clinical Trial
Official title:
Concentration of Trimethylamine Oxide (TMAO) in Blood Plasma as a Risk Factor for Vascular Cerebral Damage
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.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | May 2022 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - the ischemic changes in the brain (diagnosed by neurologist by MRI scans) Exclusion Criteria: - no ischemic changes in the brain (diagnosed by neurologist by MRI scans) |
Country | Name | City | State |
---|---|---|---|
Poland | University of Physical Education and Sport | Gdansk | Pomorskie |
Lead Sponsor | Collaborator |
---|---|
Gdansk University of Physical Education and Sport |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Brain-derived neurotrophic factor (BDNF) | BDNF concentration determined in serum by ELISA method, marked in pg/mg. | up to 4 weeks after brain MRI | |
Secondary | Mini Mental State Examination (MMSE) | MMSE is a screening tool for cognitive functions impairment. | up to 4 weeks after brain MRI | |
Secondary | Trail Making Test (TMT) | TMT test to determine the executive functions. | up to 4 weeks after brain MRI |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05971407 -
The Effect of Chronic Remote Ischaemic Preconditioning on Blood Pressure in Older Adults
|
N/A | |
Enrolling by invitation |
NCT03683186 -
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
|
Phase 3 | |
Recruiting |
NCT04584632 -
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
|
N/A | |
Recruiting |
NCT04390672 -
Multivessel TALENT
|
N/A | |
Completed |
NCT01915368 -
Determining Optimal Post-Stroke Exercise (DOSE)
|
N/A | |
Completed |
NCT01684826 -
X-ray Dose Reduction Study for Cardiac Angiography and Intervention
|
N/A | |
Completed |
NCT01417910 -
Predictors of Post Operative Outcome in Peripheral Vascular Surgical Patients
|
N/A | |
Terminated |
NCT00935766 -
Effect of Fish Oil (Omega-3 Fatty Acids) on Arteries
|
Phase 3 | |
Unknown status |
NCT01748383 -
The Long-term and Short-term Efficacy and Safety of Transplantation Autologous Bone Marrow Cells (BMCs) in Patients With the First STEMI (ST Segment Elevation Myocardial Infarction)
|
Phase 2 | |
Recruiting |
NCT05907564 -
Aventus Thrombectomy System Pulmonary Embolism Clinical Study
|
N/A | |
Recruiting |
NCT03732612 -
Inflammation in Vascular Disease
|
||
Completed |
NCT00000614 -
Prevention of Recurrent Venous Thromboembolism (PREVENT)
|
Phase 3 | |
Completed |
NCT00000530 -
Raynaud's Treatment Study (RTS)
|
Phase 3 | |
Completed |
NCT00000479 -
Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer
|
Phase 3 | |
Completed |
NCT00000539 -
Arterial Disease Multifactorial Intervention Trial (ADMIT)
|
Phase 3 | |
Completed |
NCT00000474 -
Prevention and Treatment of Hypertension Study (PATHS)
|
Phase 3 | |
Completed |
NCT00000528 -
Trials of Hypertension Prevention (TOHP)
|
Phase 3 | |
Completed |
NCT00000509 -
Potassium and Sodium to Control Blood Pressure in Hypertensives
|
Phase 3 | |
Completed |
NCT00000501 -
Hypertension Prevention Trial (HPT) Feasibility Study
|
Phase 2 | |
Completed |
NCT00000499 -
Systolic Hypertension in the Elderly Program (SHEP) (Pilot Study)
|
Phase 2 |