Heart and Ischemic STrOke Relationship studY (HISTORY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University Hospital Olomouc
Sponsor:
Collaborators:
Ministry of Health, Czech Republic
Palacky University
Information provided by (Responsible Party):
Michal Kral, University Hospital Olomouc
ClinicalTrials.gov Identifier:
NCT01541163
First received: February 23, 2012
Last updated: September 25, 2014
Last verified: September 2014

February 23, 2012
September 25, 2014
September 2010
May 2015   (final data collection date for 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. ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01541163 on ClinicalTrials.gov Archive Site
Correlation between location and volume of brain infarction. [ Time Frame: At admission within 12 hours after stroke onset and after 24hours. ] [ Designated as safety issue: No ]
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Heart and Ischemic STrOke Relationship studY
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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.

  • Brain Ischemia
  • Acute Stroke
  • Heart Diseases
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Acute Ischemic Stroke
Patients with acute ischemic stroke admitted within 12 hours after onset.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
December 2016
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • none
Both
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No
Contact: Michal Kral, MD +420 604 171 594 michal.kral@fnol.cz
Czech Republic
 
NCT01541163
NT 11046-6/2010, Grant project No.86-17
Yes
Michal Kral, University Hospital Olomouc
University Hospital Olomouc
  • Ministry of Health, Czech Republic
  • Palacky University
Study Director: Michal Kral, MD University Hospital Olomouc
University Hospital Olomouc
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP