NCT03377465

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

December 5, 2017

Last Update Submit

December 13, 2017

Conditions

Embolic Stroke of Undetermined SourceIschemic StrokeAtrial Fibrillation and FlutterMyocardial InfarctionCardiac TumorEndocarditisPatent Foramen Ovale

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Comparative group

ACTIVE COMPARATOR

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

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

Comparative groupExperimental Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stroke of undetermined cause

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31612072DERIVED

MeSH Terms

Conditions

Ischemic StrokeAtrial FibrillationMyocardial InfarctionHeart NeoplasmsEndocarditisForamen Ovale, Patent

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial IschemiaInfarctionIschemiaNecrosisThoracic NeoplasmsNeoplasms by SiteNeoplasmsHeart Septal Defects, AtrialHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2017

First Posted

December 19, 2017

Study Start

November 15, 2016

Primary Completion

November 30, 2017

Study Completion

December 5, 2017

Last Updated

December 19, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share