Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Heart and Ischemic STrOke Relationship studY (HISTORY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by University Hospital Olomouc
Ministry of Health, Czech Republic
Palacky University
Information provided by (Responsible Party):
Michal Kral, University Hospital Olomouc Identifier:
First received: February 23, 2012
Last updated: November 10, 2016
Last verified: November 2016

February 23, 2012
November 10, 2016
September 2010
September 2017   (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 ]
Not Provided
Complete list of historical versions of study NCT01541163 on 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 ]
Not Provided
Not Provided
Not Provided
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.

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.

Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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
Not Provided
Acute Ischemic Stroke
Patients with acute ischemic stroke admitted within 12 hours after onset.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2017
September 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Child, Adult, Senior
Contact: Michal Kral, MD +420 604 171 594
Czech Republic
NT 11046-6/2010, Grant project No.86-17
Not Provided
Not Provided
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
November 2016

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