Heart and Ischemic STrOke Relationship studY (HISTORY)
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|ClinicalTrials.gov Identifier: NCT01541163|
Recruitment Status : Recruiting
First Posted : February 29, 2012
Last Update Posted : November 1, 2017
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.
|Condition or disease|
|Brain Ischemia Acute Stroke Heart Diseases|
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|
|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|
Acute Ischemic Stroke
Patients with acute ischemic stroke admitted within 12 hours after onset.
- 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. ]
- Correlation between location and volume of brain infarction. [ Time Frame: At admission within 12 hours after stroke onset and after 24hours. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01541163
|Contact: Michal Kral, MD||+420 604 171 firstname.lastname@example.org|
|University Hospital Olomouc||Recruiting|
|Olomouc, Czechia, 775 20|
|Contact: Michal Kral, MD +420 604 171 594 email@example.com|
|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|