search
Back to results

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
Medical University of Lodz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Embolic Stroke of Undetermined Source

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 5, 2017
    Last Updated
    December 13, 2017
    Sponsor
    Medical University of Lodz
    search

    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

    Learn more about this trial

    Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis

    We'll reach out to this number within 24 hrs