Embolic Stroke of Undetermined SourceNCT03377465
Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis
A study testing ADMA (asymmetric dimethylarginine) , NTproBNP (N-terminal pro b-type natriuretic peptide), IL-6 (Interleukin 6), Adiponectina, Leptine, Syndecan, Resistin in people with Embolic Stroke of Undetermined Source and Ischemic Stroke, run by Medical University of Lodz.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Embolic Stroke of Undetermined Source, Ischemic Stroke, Atrial Fibrillation and Flutter
- What is being tested?
- ADMA (asymmetric dimethylarginine) , NTproBNP (N-terminal pro b-type natriuretic peptide), IL-6 (Interleukin 6), Adiponectina, Leptine, Syndecan, Resistin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2016to 5 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- stroke of undetermined cause
Who cannot join
- unstable hypertension
- atrial fibrillation
- hyperthyroidism hard
- pregnancy and breastfeeding
- dialysis
- cancer
Show all 9Show fewer
- autoimmunologic disease
- active infection
- incapable of giving agreement
About this study
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.
Read more
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.
- Conditions
- Embolic Stroke of Undetermined Source, Ischemic Stroke, Atrial Fibrillation and Flutter, Myocardial Infarction, Cardiac Tumor, Endocarditis
- Being tested
- ADMA (asymmetric dimethylarginine) , NTproBNP (N-terminal pro b-type natriuretic peptide), IL-6 (Interleukin 6), Adiponectina, Leptine, Syndecan, Resistin
- Medical subject headings
- Ischemic Stroke, Atrial Fibrillation, Myocardial Infarction, Heart Neoplasms, Endocarditis, Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADMA (asymmetric dimethylarginine) , NTproBNP (N-terminal pro b-type natriuretic peptide), IL-6 (Interleukin 6), Adiponectina, Leptine, Syndecan, ResistinDiagnostic test
ADMA, NTproBNP, IL-6, Adiponectina, Leptine, Syndecan, Resistin
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Patients with stroke of undetermined cause age 18-65 Receives: Diagnostic Test: ADMA (asymmetric dimethylarginine) , NTproBNP (N-terminal pro b-type natriuretic peptide), IL-6 (Interleukin 6), Adiponectina, Leptine, Syndecan, Resistin |
| Comparative group | Active comparator | Healthy patients age 18-65 Receives: Diagnostic Test: ADMA (asymmetric dimethylarginine) , NTproBNP (N-terminal pro b-type natriuretic peptide), IL-6 (Interleukin 6), Adiponectina, Leptine, Syndecan, Resistin |
What is being measured
The primary outcome is the main question the study is designed to answer.
physiological parameter
CRP (C reactive protein)
Measured: 24 months
physiological parameter
IL-6 (interleukin 6)
Measured: 24 months
physiological parameter
ADMA (asymmetric dimethylarginine)
Measured: 24 months
physiological parameter
NTproB (N-terminal pro b-type natriuretic peptide)
Measured: 24 months
physiological parameter
Adiponectin
Measured: 24 months
physiological parameter
Leptine
Measured: 24 months
physiological parameter
Resistin
Measured: 24 months
physiological parameter
Syndecan
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start15 Nov 2016
- Primary completion30 Nov 2017
- Study completion5 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Embolic Stroke of Undetermined SourceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paulina Gąsiorek, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377465
- Sponsor's protocol ID
- 01122017
- Status last verified
- Dec 2017
- First submitted
- 5 Dec 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis
- ClinicalTrials.gov ID
- NCT03377465
- Acronym / sponsor ID
- 01122017
- Conditions
- Embolic Stroke of Undetermined Source, Ischemic Stroke, Atrial Fibrillation and Flutter, Myocardial Infarction, Cardiac Tumor, Endocarditis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 5 Dec 2017 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Diagnostic Test: ADMA (asymmetric dimethylarginine) , NTproBNP (N-terminal pro b-type natriuretic peptide), IL-6 (Interleukin 6), Adiponectina, Leptine, Syndecan, ResistinPatients with stroke of undetermined cause age 18-65 |
| Comparative group | Active comparator | Diagnostic Test: ADMA (asymmetric dimethylarginine) , NTproBNP (N-terminal pro b-type natriuretic peptide), IL-6 (Interleukin 6), Adiponectina, Leptine, Syndecan, ResistinHealthy patients age 18-65 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- stroke of undetermined cause
Key exclusion criteria (9 listed)
- unstable hypertension
- atrial fibrillation
- hyperthyroidism hard
- pregnancy and breastfeeding
- dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADMA (asymmetric dimethylarginine) , NTproBNP (N-terminal pro b-type natriuretic peptide), IL-6 (Interleukin 6), Adiponectina, Leptine, Syndecan, ResistinADMA, NTproBNP, IL-6, Adiponectina, Leptine, Syndecan, Resistin | Diagnostic test | Comparative group, Experimental Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Derived from this study: PubMed 31612072Gasiorek 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ADMA (asymmetric dimethylarginine) , NTproBNP (N-terminal pro b-type natriuretic peptide), IL-6 (Interleukin 6), Adiponectina, Leptine, Syndecan, Resistin in people with Embolic Stroke of Undetermined Source and Ischemic Stroke, run by Medical University of Lodz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physiological parameter (time frame: 24 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03377465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.