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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Embolic Stroke of Undetermined Source Ischemic Stroke Atrial Fibrillation and Flutter Myocardial Infarction Cardiac Tumor Endocarditis Patent Foramen Ovale Diagnostic Test: ADMA (asymmetric dimethylarginine) , NTproBNP (N-terminal pro b-type natriuretic peptide), IL-6 (Interleukin 6), Adiponectina, Leptine, Syndecan, Resistin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis
Actual Study Start Date : November 15, 2016
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : December 5, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Group
Patients with stroke of undetermined cause age 18-65
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

Active Comparator: Comparative group
Healthy patients age 18-65
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




Primary Outcome Measures :
  1. physiological parameter [ Time Frame: 24 months ]
    CRP (C reactive protein)

  2. physiological parameter [ Time Frame: 24 months ]
    IL-6 (interleukin 6)

  3. physiological parameter [ Time Frame: 24 months ]
    ADMA (asymmetric dimethylarginine)

  4. physiological parameter [ Time Frame: 24 months ]
    NTproB (N-terminal pro b-type natriuretic peptide)

  5. physiological parameter [ Time Frame: 24 months ]
    Adiponectin

  6. physiological parameter [ Time Frame: 24 months ]
    Leptine

  7. physiological parameter [ Time Frame: 24 months ]
    Resistin

  8. physiological parameter [ Time Frame: 24 months ]
    Syndecan



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paulina Gąsiorek, Principal Investigator, Medical Universtity of Lodz
ClinicalTrials.gov Identifier: NCT03377465    
Other Study ID Numbers: 01122017
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Neoplasms
Stroke
Cerebral Infarction
Atrial Fibrillation
Myocardial Infarction
Endocarditis
Foramen Ovale, Patent
Ischemia
Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Necrosis
Myocardial Ischemia
Brain Infarction
Brain Ischemia
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Thoracic Neoplasms
Neoplasms by Site
Neoplasms