ClinicalTrials.gg
CompletedNCT03377465Updated Dec 19, 2017

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

An interventional study of ADMA (asymmetric dimethylarginine) , NTproBNP (N-terminal pro b-type natriuretic peptide), IL-6 (Interleukin 6), Adiponectina, Leptine, Syndecan, Resistin in Embolic Stroke of Undetermined Source, Ischemic Stroke and Atrial Fibrillation and Flutter, sponsored by Medical University of Lodz. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-19.

Sponsored by Medical University of Lodz · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Nov 2016, registered Dec 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Embolic Stroke of Undetermined Source
  • Ischemic Stroke
  • Atrial Fibrillation and Flutter
  • Myocardial Infarction
  • Cardiac Tumor
  • Endocarditis
  • Patent Foramen Ovale
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's enrollment of 100 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Medical University of Lodz is the lead sponsor of 107 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • stroke of undetermined cause

Exclusion criteria

Exclusion Criteria:

  • unstable hypertension
  • atrial fibrillation
  • hyperthyroidism hard
  • pregnancy and breastfeeding
  • dialysis
  • cancer
  • autoimmunologic disease
  • active infection
  • incapable of giving agreement
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
100 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Diagnostic testADMA (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

06

What researchers measure

Primary outcomes

  1. physiological parameter

    CRP (C reactive protein)

    Time frame: 24 months

  2. physiological parameter

    IL-6 (interleukin 6)

    Time frame: 24 months

  3. physiological parameter

    ADMA (asymmetric dimethylarginine)

    Time frame: 24 months

  4. physiological parameter

    NTproB (N-terminal pro b-type natriuretic peptide)

    Time frame: 24 months

  5. physiological parameter

    Adiponectin

    Time frame: 24 months

  6. physiological parameter

    Leptine

    Time frame: 24 months

  7. physiological parameter

    Resistin

    Time frame: 24 months

  8. physiological parameter

    Syndecan

    Time frame: 24 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 31612072 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03377465
Responsible party
Paulina Gąsiorek (Principal Investigator, Medical University of Lodz) — Principal investigator
First posted
Dec 19, 2017
Start date
Nov 15, 2016
Primary completion
Nov 30, 2017
Completion
Dec 5, 2017
Last update
Dec 19, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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