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

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ClinicalTrials.gov Identifier: NCT03377465
Recruitment Status : Completed
First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Paulina Gąsiorek, Medical Universtity of Lodz

Tracking Information
First Submitted Date  ICMJE December 5, 2017
First Posted Date  ICMJE December 19, 2017
Last Update Posted Date December 19, 2017
Actual Study Start Date  ICMJE November 15, 2016
Actual Primary Completion Date November 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2017)
  • physiological parameter [ Time Frame: 24 months ]
    CRP (C reactive protein)
  • physiological parameter [ Time Frame: 24 months ]
    IL-6 (interleukin 6)
  • physiological parameter [ Time Frame: 24 months ]
    ADMA (asymmetric dimethylarginine)
  • physiological parameter [ Time Frame: 24 months ]
    NTproB (N-terminal pro b-type natriuretic peptide)
  • physiological parameter [ Time Frame: 24 months ]
    Adiponectin
  • physiological parameter [ Time Frame: 24 months ]
    Leptine
  • physiological parameter [ Time Frame: 24 months ]
    Resistin
  • physiological parameter [ Time Frame: 24 months ]
    Syndecan
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis
Official Title  ICMJE Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Embolic Stroke of Undetermined Source
  • Ischemic Stroke
  • Atrial Fibrillation and Flutter
  • Myocardial Infarction
  • Cardiac Tumor
  • Endocarditis
  • Patent Foramen Ovale
Intervention  ICMJE Diagnostic Test: ADMA (asymmetric dimethylarginine) , NTproBNP (N-terminal pro b-type natriuretic peptide), IL-6 (Interleukin 6), Adiponectina, Leptine, Syndecan, Resistin
ADMA, NTproBNP, IL-6, Adiponectina, Leptine, Syndecan, Resistin
Study Arms  ICMJE
  • Experimental: Experimental Group
    Patients with stroke of undetermined cause age 18-65
    Intervention: Diagnostic Test: ADMA (asymmetric dimethylarginine) , NTproBNP (N-terminal pro b-type natriuretic peptide), IL-6 (Interleukin 6), Adiponectina, Leptine, Syndecan, Resistin
  • Active Comparator: Comparative group
    Healthy patients age 18-65
    Intervention: Diagnostic Test: ADMA (asymmetric dimethylarginine) , NTproBNP (N-terminal pro b-type natriuretic peptide), IL-6 (Interleukin 6), Adiponectina, Leptine, Syndecan, Resistin
Publications * Gąsiorek 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2017)
100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 5, 2017
Actual Primary Completion Date November 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03377465
Other Study ID Numbers  ICMJE 01122017
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  ICMJE
Plan to Share IPD: No
Responsible Party Paulina Gąsiorek, Medical Universtity of Lodz
Study Sponsor  ICMJE Medical Universtity of Lodz
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical Universtity of Lodz
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP