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AzTrials

Brain IschemiaHISTORYNCT01541163

Heart and Ischemic STrOke Relationship studY

An observational study of Brain Ischemia and Acute Stroke, run by University Hospital Olomouc at 1 site in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Brain Ischemia, Acute Stroke, Heart Diseases
How many people
500 participants
Where
1 siteCzechia
Study dates
Sep 2010to Nov 2018
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Consecutive ischemic stroke patients within 12 hours from stroke onset, who will be admitted at Comprehensive Stroke Center, Department of Neurology, University Hospital Olomouc from the October 2010 until December 2015.

Who may be able to join

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

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country.

Michal Kral, MD contact

+420 604 171 594

michal.kral@fnol.cz

Czechia1 site, 1 recruiting

  • University Hospital Olomouc

    Olomouc, 775 20

    Michal Kral, MD, +420 604 171 594, michal.kral@fnol.cz

    Michal Kral, MD

    Recruiting

Other trials in Czechia

About this study

Official title: Assessment of Relationship Between Acute Ischemic Stroke and Heart Disease

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.
Read the detailed description

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.

Keywords
Ischemia, Brain Infarction, Acute Stroke, Heart Diseases, Myocardial Infarction
Medical subject headings
Brain Ischemia, Stroke, Heart Diseases, Ischemia, Brain Infarction, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01541163
Study groupRoleWhat they receive
Acute Ischemic StrokePatients with acute ischemic stroke admitted within 12 hours after onset.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the serum level profile of cardiac troponin T (cTnT) in acute ischemic stroke (AIS) patients and to evaluate factors associated with increased serum level of cTnT.

    Measured: Within 12 hours after ischemic stroke onset.

Secondary outcomes (1)

  1. Correlation between location and volume of brain infarction.

    Measured: At admission within 12 hours after stroke onset and after 24hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2012 (estimated)
  2. Study startSep 2010
  3. Primary completionJun 2018 (estimated)
  4. Study completionNov 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01541163
Sponsor's protocol ID
NT 11046-6/2010
Other IDs
Grant project No.86-17
Acronym
HISTORY
Status last verified
Oct 2017
First submitted
23 Feb 2012
Last updated
1 Nov 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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. 2026 Mar;170(1):20-25. doi: 10.5507/bp.2024.024. Epub 2024 Jul 16.

    PubMed 39023063

  • 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.

    PubMed 34623123

  • 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.

    PubMed 32912364

  • 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.

    PubMed 32807456

  • 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.

    PubMed 32563078

  • 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.

    PubMed 25916280

  • 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.

    PubMed 25573455

  • 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.

    PubMed 25497535

  • 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.

    PubMed 23069890

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Ischemia and Acute Stroke, run by University Hospital Olomouc at 1 site in Czechia.

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 1 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: status not confirmed, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michal Kral, MD (+420 604 171 594, michal.kral@fnol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the serum level profile of cardiac troponin T (cTnT) in acute ischemic stroke (AIS) patients and to evaluate factors associated with increased serum level of cTnT. (time frame: Within 12 hours after ischemic stroke onset.). 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 NCT01541163, which also lists 9 linked publications.

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 1 Nov 2017.

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