Heart and Ischemic STrOke Relationship studY (HISTORY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01541163
Recruitment Status : Recruiting
First Posted : February 29, 2012
Last Update Posted : November 1, 2017
Ministry of Health, Czech Republic
Palacky University
Information provided by (Responsible Party):
Michal Kral, University Hospital Olomouc

February 23, 2012
February 29, 2012
November 1, 2017
September 2010
June 2018   (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. ]
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. ]
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.

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.

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.
Same as current
November 2018
June 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Sexes Eligible for Study: All
Child, Adult, Older Adult
Contact: Michal Kral, MD +420 604 171 594
Czech Republic
NT 11046-6/2010
Grant project No.86-17 ( Other Identifier: University Hospital Olomouc )
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
October 2017