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NCT01541163 Clinical Trial

Heart and Ischemic STrOke Relationship studY

Heart Diseases Clinical Trial

— HISTORY  

Official title:
Assessment of Relationship Between Acute Ischemic Stroke and Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01541163
Other study ID # NT 11046-6/2010
Secondary ID Grant project No
Status Recruiting
Phase N/A
First received February 23, 2012
Last updated October 31, 2017
Start date September 2010
Est. completion date November 2018

Study information
Verified date October 2017
Source University Hospital Olomouc
Contact Michal Kral, MD
Phone +420 604 171 594
Email michal.kral@fnol.cz
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date November 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Czechia University Hospital Olomouc Olomouc

Sponsors (3)
Lead Sponsor Collaborator
University Hospital Olomouc Ministry of Health, Czech Republic, Palacky University

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Correlation between location and volume of brain infarction. At admission within 12 hours after stroke onset and after 24hours.
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