Heart and Ischemic STrOke Relationship studY

• Conditions: Brain Ischemia; Acute Stroke; Heart Diseases

• Registration Number: NCT01541163
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-02-28
• Study First Posted: 2012-02-29
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-01
• Primary Completion: 2018-06
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Within 12 hours after ischemic stroke onset.

Secondary Outcome Measures

Name	Time	Method
Correlation between location and volume of brain infarction.	At admission within 12 hours after stroke onset and after 24hours.

Trial Locations

Locations (1)

University Hospital Olomouc; 🇨🇿 Olomouc, Czechia