Heart and Ischemic STrOke Relationship studY (HISTORY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University Hospital Olomouc
Sponsor:
Collaborators:
Ministry of Health, Czech Republic
Palacky University
Information provided by (Responsible Party):
Michal Kral, University Hospital Olomouc
ClinicalTrials.gov Identifier:
NCT01541163
First received: February 23, 2012
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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
Brain Ischemia
Acute Stroke
Heart Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Relationship Between Acute Ischemic Stroke and Heart Disease

Resource links provided by NLM:


Further study details as provided by University Hospital Olomouc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: September 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acute Ischemic Stroke
Patients with acute ischemic stroke admitted within 12 hours after onset.

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.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541163

Contacts
Contact: Michal Kral, MD +420 604 171 594 michal.kral@fnol.cz

Locations
Czech Republic
University Hospital Olomouc Recruiting
Olomouc, Czech Republic, 775 20
Contact: Michal Kral, MD    +420 604 171 594    michal.kral@fnol.cz   
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
Investigators
Study Director: Michal Kral, MD University Hospital Olomouc
  More Information

Additional Information:
No publications provided by University Hospital Olomouc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michal Kral, Study Director, University Hospital Olomouc
ClinicalTrials.gov Identifier: NCT01541163     History of Changes
Other Study ID Numbers: NT 11046-6/2010, Grant project No.86-17
Study First Received: February 23, 2012
Last Updated: September 25, 2014
Health Authority: Czech Republic: Ethics Committee

Keywords provided by University Hospital Olomouc:
Ischemia
Brain Infarction
Acute Stroke
Heart Diseases
Myocardial Infarction

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

ClinicalTrials.gov processed this record on October 23, 2014