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

Brief 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. 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.

Condition or disease
Brain Ischemia Acute Stroke Heart Diseases

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.

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Relationship Between Acute Ischemic Stroke and Heart Disease
Study Start Date : September 2010
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

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

Primary Outcome Measures :
  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. [ Time Frame: Within 12 hours after ischemic stroke onset. ]

Secondary Outcome Measures :
  1. Correlation between location and volume of brain infarction. [ Time Frame: At admission within 12 hours after stroke onset and after 24hours. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

Inclusion Criteria:

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

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01541163

Contact: Michal Kral, MD +420 604 171 594

University Hospital Olomouc Recruiting
Olomouc, Czechia, 775 20
Contact: Michal Kral, MD    +420 604 171 594   
Principal Investigator: Michal Kral, MD         
Sub-Investigator: Daniel Sanak, MD,PhD         
Sub-Investigator: Tomas Veverka, MD.         
Sub-Investigator: David Skoloudik, MD,PhD,prof.         
Sub-Investigator: Roman Herzig, MD,PhD,prof.         
Sub-Investigator: Andrea Bartkova, MD., PhD.         
Sub-Investigator: Martin Hutyra, MD., PhD.         
Sub-Investigator: David Vindis, MD.         
Sub-Investigator: Petr Kanovsky, MD,PhD,prof.         
Sub-Investigator: Anna Kuncarova         
Sub-Investigator: Milos Taborsky, MD,PhD,prof.         
Sub-Investigator: Tomas Skala, MD, PhD.         
Sponsors and Collaborators
University Hospital Olomouc
Ministry of Health, Czech Republic
Palacky University
Study Director: Michal Kral, MD University Hospital Olomouc

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michal Kral, Study Director, University Hospital Olomouc Identifier: NCT01541163     History of Changes
Other Study ID Numbers: NT 11046-6/2010
Grant project No.86-17 ( Other Identifier: University Hospital Olomouc )
First Posted: February 29, 2012    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017

Keywords provided by Michal Kral, University Hospital Olomouc:
Brain Infarction
Acute Stroke
Heart Diseases
Myocardial Infarction

Additional relevant MeSH terms:
Heart Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia
Pathologic Processes