Heart and Ischemic STrOke Relationship studY (HISTORY)
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:
- 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)
- higher number of etiologically determinated IS, which is crucial for accurate secondary prevention.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Assessment of Relationship Between Acute Ischemic Stroke and Heart Disease|
- 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 ]
- 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 ]
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Acute Ischemic Stroke
Patients with acute ischemic stroke admitted within 12 hours after onset.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541163
|Contact: Michal Kral, MD||+420 604 171 email@example.com|
|University Hospital Olomouc||Recruiting|
|Olomouc, Czech Republic, 775 20|
|Contact: Michal Kral, MD +420 604 171 594 firstname.lastname@example.org|
|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.|
|Study Director:||Michal Kral, MD||University Hospital Olomouc|