Heart and Ischemic STrOke Relationship studY (HISTORY)
|First Received Date ICMJE||February 23, 2012|
|Last Updated Date||October 21, 2013|
|Start Date ICMJE||September 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01541163 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Heart and Ischemic STrOke Relationship studY|
|Official Title ICMJE||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:
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||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.
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Acute Ischemic Stroke
Patients with acute ischemic stroke admitted within 12 hours after onset.
|Publications *||Kral M, Skoloudik D, Sanak D, Veverka T, Bartkova A, Dornak T, Hutyra M, Vindis D, Ulehlova J, Slavik L, Svabova M, Kubickova V, Herzig R, Kanovsky P. Assessment of relationship between acute ischemic stroke and heart disease--protocol of a prospective observational trial. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2012 Sep;156(3):284-9. doi: 10.5507/bp.2012.094. Epub 2012 Oct 4.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||500|
|Estimated Completion Date||December 2015|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Czech Republic|
|NCT Number ICMJE||NCT01541163|
|Other Study ID Numbers ICMJE||NT 11046-6/2010, Grant project No.86-17|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Michal Kral, University Hospital Olomouc|
|Study Sponsor ICMJE||University Hospital Olomouc|
|Information Provided By||University Hospital Olomouc|
|Verification Date||October 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP