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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Ischemic Stroke; Endocarditis; Patent Foramen Ovale; Embolic Stroke of Undetermined Source; Atrial Fibrillation and Flutter; Cardiac Tumor
• Intervention / Treatment: Diagnostic test: ADMA (asymmetric dimethylarginine) , NTproBNP (N-terminal pro b-type natriuretic peptide), IL-6 (Interleukin 6), Adiponectina, Leptine, Syndecan, Resistin

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: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
physiological parameter	CRP (C reactive protein)	24 months
physiological parameter	IL-6 (interleukin 6)	24 months
physiological parameter	ADMA (asymmetric dimethylarginine)	24 months
physiological parameter	NTproB (N-terminal pro b-type natriuretic peptide)	24 months
physiological parameter	Adiponectin	24 months
physiological parameter	Leptine	24 months
physiological parameter	Resistin	24 months
physiological parameter	Syndecan	24 months

Collaborators and Investigators

• Sponsor: Medical University of Lodz

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 15, 2016
• Primary Completion (ACTUAL): November 30, 2017
• Study Completion (ACTUAL): December 5, 2017

Study Registration Dates

• First Submitted: December 5, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (ACTUAL): December 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Congenital Abnormalities; Thoracic Neoplasms; Arrhythmias, Cardiac; Brain Ischemia; Infarction; Brain Infarction; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects, Atrial; Heart Septal Defects; Myocardial Infarction; Stroke; Ischemic Stroke; Ischemia; Atrial Fibrillation; Cerebral Infarction; Endocarditis; Foramen Ovale, Patent; Embolic Stroke; Heart Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Natriuretic Agents; Natriuretic Peptide, Brain; N,N-dimethylarginine
• Other Study ID Numbers: 01122017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No