Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis
Primary Purpose
Embolic Stroke of Undetermined Source, Ischemic Stroke, Atrial Fibrillation and Flutter
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ADMA (asymmetric dimethylarginine) , NTproBNP (N-terminal pro b-type natriuretic peptide), IL-6 (Interleukin 6), Adiponectina, Leptine, Syndecan, Resistin
Sponsored by
About this trial
This is an interventional prevention trial for Embolic Stroke of Undetermined Source
Eligibility Criteria
Inclusion Criteria:
- stroke of undetermined cause
Exclusion Criteria:
- unstable hypertension
- atrial fibrillation
- hyperthyroidism hard
- pregnancy and breastfeeding
- dialysis
- cancer
- autoimmunologic disease
- active infection
- incapable of giving agreement
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group
Comparative group
Arm Description
Patients with stroke of undetermined cause age 18-65
Healthy patients age 18-65
Outcomes
Primary Outcome Measures
physiological parameter
CRP (C reactive protein)
physiological parameter
IL-6 (interleukin 6)
physiological parameter
ADMA (asymmetric dimethylarginine)
physiological parameter
NTproB (N-terminal pro b-type natriuretic peptide)
physiological parameter
Adiponectin
physiological parameter
Leptine
physiological parameter
Resistin
physiological parameter
Syndecan
Secondary Outcome Measures
Full Information
NCT ID
NCT03377465
First Posted
December 5, 2017
Last Updated
December 13, 2017
Sponsor
Medical University of Lodz
1. Study Identification
Unique Protocol Identification Number
NCT03377465
Brief Title
Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis
Official Title
Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 15, 2016 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
December 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Lodz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A stroke is the second cause of deaths after heart attack, one of the most important causes of malfunction as far as adults are concerned and the second as for the frequency cause of dementia. In spite of a possibility of the therapy of stroke ( tissue plasminogen activator) and recognized most of risk factors there is expected that incidence rate on stroke connected with ageing of the society will be growing. It will cause medical and social consequences.
There are many of potential causes of cardiac strokes, which are not entirely examined.
More over many cryptogenic strokes are presumed to have an embolic etiology, and the frequent cause of these kind of strokes at young age is probably the mechanism of paradoxical embolism through patent foramen ovale.
As far as the investigators are concerned, at present there is lack of any recommendations for these scientific hypothesis.
Detailed Description
A stroke is the second cause of deaths after heart attack, one of the most important causes of malfunction as far as adults are concerned and the second as for the frequency cause of dementia. In spite of a possibility of the therapy of stroke ( tissue plasminogen activator) and recognized most of risk factors there is expected that incidence rate on stroke connected with ageing of the society will be growing. It will cause medical and social consequences.
The risk factors of stroke can be divided into alterable and not alterable. Importantly, the not alterable factors are: age, sex, race and genetic factors. After the age of 55 the risk of stroke grows twice in every decade of life. Moreover, it was alleged that incidence rate on stroke is more frequent at women than at men. At the black race the incidence rate on stroke is twice more frequent than at white race.
Well- known are also genetic syndromes connected with strokes like s. MELAS or CADASIL.
Well- known alterable factors are:
hypertension
coronary disease
atrial fibrillation
hypercholesterolemia
diabetes
nicotinism
blood clotting disorder
alcoholism
TIA (transient ischemic attack) or previous former stroke
asymptomatic stenosis of internal carotid artery
Cardiogenic stroke is a stroke caused by embolic material, which was created in cardiac cavities or on cardiac valves. They comprised 11% of all strokes and 25% of ischemic strokes. Additionally, among patients over 80 years old cardiac causes are responsible for even 40% of all ischemic strokes and half of cardiogenic strokes is caused of atrial fibrillation. Among young people (below 45 years old) about 50% of strokes are cardiogenic and are connected with paradoxical embolism at patients with patent foramen ovale.
Furthermore, cardiac- brain embolism is a result of:
structural defect of cavities and valves of heart
arrhythmia
disturbances of movability of walls of the heart and function of endocardium which leads to increased risk of the risk of parietal thrombus
cardiac insufficiency
There are many of potential causes of cardiac strokes, which are not entirely examined as for example:
small pockets of intra- atrial septum
structures in dextral atrium like Eustachian valve or Chiari network
there is also a theory that even enlargement of left atrium may be the cause of brain stroke
aneurysm of intra- atrial septum.
As far as the investigators are concerned, at present there is lack of any recommendations for these scientific hypothesis.
Available data suggest that in the comparison with atherosclerosis and lacunar strokes cardiogenic strokes characterize with high mortality ranging of 27%. Also the risk of relapse is higher than in strokes of other etiology.
Nevertheless, unfortunately, in spite of wide diagnostics at about 25-30% of patients with ischemic stroke the cause is unknown. This kind of stroke is called cryptogenic stroke or stroke with undefined etiology.
They constitute almost half of all ischemic stroke at young patients (below 55 years old). Many cryptogenic strokes are presumed to have an embolic etiology, and the frequent cause of these kind of strokes at young age is probably the mechanism of paradoxical embolism through patent foramen ovale.
To conclude, currently there aren't researches defining recommendations for long- lasting treatment patients with rare causes of strokes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Embolic Stroke of Undetermined Source, Ischemic Stroke, Atrial Fibrillation and Flutter, Myocardial Infarction, Cardiac Tumor, Endocarditis, Patent Foramen Ovale
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Patients with stroke of undetermined cause age 18-65
Arm Title
Comparative group
Arm Type
Active Comparator
Arm Description
Healthy patients age 18-65
Intervention Type
Diagnostic Test
Intervention Name(s)
ADMA (asymmetric dimethylarginine) , NTproBNP (N-terminal pro b-type natriuretic peptide), IL-6 (Interleukin 6), Adiponectina, Leptine, Syndecan, Resistin
Intervention Description
ADMA, NTproBNP, IL-6, Adiponectina, Leptine, Syndecan, Resistin
Primary Outcome Measure Information:
Title
physiological parameter
Description
CRP (C reactive protein)
Time Frame
24 months
Title
physiological parameter
Description
IL-6 (interleukin 6)
Time Frame
24 months
Title
physiological parameter
Description
ADMA (asymmetric dimethylarginine)
Time Frame
24 months
Title
physiological parameter
Description
NTproB (N-terminal pro b-type natriuretic peptide)
Time Frame
24 months
Title
physiological parameter
Description
Adiponectin
Time Frame
24 months
Title
physiological parameter
Description
Leptine
Time Frame
24 months
Title
physiological parameter
Description
Resistin
Time Frame
24 months
Title
physiological parameter
Description
Syndecan
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
stroke of undetermined cause
Exclusion Criteria:
unstable hypertension
atrial fibrillation
hyperthyroidism hard
pregnancy and breastfeeding
dialysis
cancer
autoimmunologic disease
active infection
incapable of giving agreement
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31612072
Citation
Gasiorek P, Sakowicz A, Banach M, von Haehling S, Bielecka-Dabrowa A. Arterial Stiffness and Indices of Left Ventricular Diastolic Dysfunction in Patients with Embolic Stroke of Undetermined Etiology. Dis Markers. 2019 Sep 12;2019:9636197. doi: 10.1155/2019/9636197. eCollection 2019.
Results Reference
derived
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Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis
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