Heart and Ischemic STrOke Relationship studY

NCT ID: NCT01541163

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2018-11-30

Brief Summary

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Although cardio-embolic etiology of ischemic stroke (IS) is largely respected, there is still no clear recommendation for routine complex cardiological examination in all IS patients. Using complex cardiological examination the investigators expect:

1. more accurate detection of patients with concomitant heart disease (cardiac rhythm disorder, valve disorders, acute coronary syndrome, cardiac thrombus and myxoma, atrial and ventricle septum defects)
2. higher number of etiologically determinated IS, which is crucial for accurate secondary prevention.

Detailed Description

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The investigators expect significant changes of biochemical parameters (NT pro B-type of natriuretic peptide, pro-atrial natriuretic peptide, creatinkinase MB, troponin T), inflammatory markers (interleukine 6, procalcitonin, high sensitive C-reactive protein), and coagulation parameters in patients with CE IS compared to other causes of IS.

Assessing the glomerular filtration of cystatin C, glycated haemoglobin and serum lipids and its correlation with prior medicament use will allow to evaluate the long-term compensation of arterial hypertension, diabetes mellitus and dyslipidemia in IS patients.

In addition to the above mentioned comprehensive cardiological examinations, 1- and 3-week ECG-Holter will be performed in subpopulation of patients old up to 50 years and with cryptogenic ischemic stroke in the period from 1st May 2013 to 31st December 2015. These patients will also fill in a special epidemiologic questionnaire. Anticipated enrollment in this substudy of HISTORY study is 40 - 80 patients.

In selected young cryptogenic stroke patients, a subcutaneous cardiac monitor was implanted for the detection of paroxysmal atrial fibrillation in the period from 1st January 2014 to 31st December 2015.

From 2016 in young ischemic stroke (IS) patients under 50 years, a standard perfusion/ventilation scintigraphy of lungs will be performed to exclude acute pulmonary embolization (coincidental) in case of elevated serum D-dimers after admission.

In all enrolled young IS patients, a BP Holter will be performed after the discharge home to exclude possible arterial hypertension, which did not presented during hospitalization.

Conditions

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Brain Ischemia Acute Stroke Heart Diseases

Keywords

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Ischemia Brain Infarction Acute Stroke Heart Diseases Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute Ischemic Stroke

Patients with acute ischemic stroke admitted within 12 hours after onset.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Ischemic stroke admitted within 12 hours from stroke onset at stroke center

Exclusion Criteria

* none
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Czech Republic

OTHER_GOV

Sponsor Role collaborator

Palacky University

OTHER

Sponsor Role collaborator

University Hospital Olomouc

OTHER

Sponsor Role lead

Responsible Party

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Michal Kral

Study Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michal Kral, MD

Role: STUDY_DIRECTOR

University Hospital Olomouc

Locations

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University Hospital Olomouc

Olomouc, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Michal Kral, MD

Role: CONTACT

Phone: +420 604 171 594

Email: [email protected]

Facility Contacts

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Michal Kral, MD

Role: primary

References

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Franc D, Sanak D, Kral M, Hutyra M, Taborsky M, Divisova P, Zapletalova J. Impact of prior oral anticoagulation on admission stroke severity in patients with atrial fibrillation. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2024 Jul 16. doi: 10.5507/bp.2024.024. Online ahead of print.

Reference Type DERIVED
PMID: 39023063 (View on PubMed)

Franc D, Sanak D, Divisova P, Lyskova L, Bartkova A, Zapletalova J, Kral M, Dornak T, Polidar P, Veverka T, Kanovsky P. Socioeconomic status and lifestyle in young ischaemic stroke patients: a possible relationship to stroke recovery and risk of recurrent event. Cent Eur J Public Health. 2021 Sep;29(3):223-229. doi: 10.21101/cejph.a6697.

Reference Type DERIVED
PMID: 34623123 (View on PubMed)

Divisova P, Sanak D, Vaclavik J, Kral M, Hutyra M, Zapletalova J, Bartkova A, Franc D, Dornak T, Veverka T, Taborsky M, Kanovsky P. Arterial Hypertension and Risk of Recurrent Event in Young Ischemic Stroke Patients. Can J Neurol Sci. 2021 May;48(3):358-364. doi: 10.1017/cjn.2020.200. Epub 2020 Sep 11.

Reference Type DERIVED
PMID: 32912364 (View on PubMed)

Divisova P, Sanak D, Kral M, Bartkova A, Hutyra M, Zapletalova J, Dornak T, Spacek M, Franc D, Polidar P, Veverka T, Kanovsky P. Young cryptogenic ischemic stroke: A descriptive analysis of clinical and laboratory characteristics, outcomes and stroke recurrence. J Stroke Cerebrovasc Dis. 2020 Sep;29(9):105046. doi: 10.1016/j.jstrokecerebrovasdis.2020.105046. Epub 2020 Jun 23.

Reference Type DERIVED
PMID: 32807456 (View on PubMed)

Sanak D, Divisova P, Hutyra M, Kral M, Bartkova A, Zapletalova J, Latal J, Dornak T, Hudec S, Franc D, Polidar P, Veverka T, Kanovsky P. Risk of recurrent ischemic stroke in young cryptogenic patients with embolic stroke of undetermined source. J Neurol Sci. 2020 Sep 15;416:116985. doi: 10.1016/j.jns.2020.116985. Epub 2020 Jun 13.

Reference Type DERIVED
PMID: 32563078 (View on PubMed)

Sanak D, Hutyra M, Kral M, Bartkova A, Zapletalova J, Fedorco M, Veverka T, Vindis D, Dornak T, Skala T, Skoloudik D, Taborsky M, Kanovsky P. Paroxysmal atrial fibrillation in young cryptogenic ischemic stroke: A 3-week ECG Holter monitoring study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2015 Jun;159(2):283-7. doi: 10.5507/bp.2015.019. Epub 2015 Apr 24.

Reference Type DERIVED
PMID: 25916280 (View on PubMed)

Sanak D, Hutyra M, Kral M, Bartkova A, Zapletalova J, Fedorco M, Veverka T, Vindis D, Dornak T, Skala T, Skoloudik D, Taborsky M, Kanovsky P. Atrial fibrillation in young ischemic stroke patients: an underestimated cause? Eur Neurol. 2015;73(3-4):158-63. doi: 10.1159/000369793. Epub 2015 Jan 8.

Reference Type DERIVED
PMID: 25573455 (View on PubMed)

Kral M, Sanak D, Veverka T, Hutyra M, Vindis D, Bartkova A, Kuncarova A, Dornak T, Cechakova E, Herzig R, Langova K, Kanovsky P, Skoloudik D. Troponin T: Correlation with location and volume of acute brain infarction. Int J Cardiol. 2015 Feb 15;181:127-32. doi: 10.1016/j.ijcard.2014.12.027. Epub 2014 Dec 3.

Reference Type DERIVED
PMID: 25497535 (View on PubMed)

Kral M, Skoloudik D, Sanak D, Veverka T, Bartkova A, Dornak T, Hutyra M, Vindis D, Ulehlova J, Slavik L, Svabova M, Kubickova V, Herzig R, Kanovsky P. Assessment of relationship between acute ischemic stroke and heart disease--protocol of a prospective observational trial. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2012 Sep;156(3):284-9. doi: 10.5507/bp.2012.094. Epub 2012 Oct 4.

Reference Type DERIVED
PMID: 23069890 (View on PubMed)

Related Links

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http://www.fnol.cz/

University Hospital Olomouc

http://www.mzcr.cz/

Ministry of Health of Czech Republic

http://biomed.papers.upol.cz/pdfs/bio/2012/03/16.pdf

Biomedical Papers - Protocol of a prospective observational trial

http://www.ncbi.nlm.nih.gov/pubmed/23566538

Kral M et al. Troponin T in Acute Ischemic Stroke. Am J Cardiol. 2013 Jul 1;112(1):117-21. Epub 2013 Apr 6.

Other Identifiers

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Grant project No.86-17

Identifier Type: OTHER

Identifier Source: secondary_id

NT 11046-6/2010

Identifier Type: -

Identifier Source: org_study_id