HISTORY: Heart and Ischemic STrOke Relationship studY

Sponsor

University Hospital Olomouc (Other)

Overall Status

Unknown status

CT.gov ID

NCT01541163

Collaborator

Ministry of Health, Czech Republic (Other), Palacky University (Other)

500

Enrollment

Location

Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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:

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	Intervention/Treatment	Phase
Brain Ischemia Acute Stroke Heart Diseases

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 Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Assessment of Relationship Between Acute Ischemic Stroke and Heart Disease

Study Start Date :

Sep 1, 2010

Anticipated Primary Completion Date :

Jun 1, 2018

Anticipated Study Completion Date :

Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Acute Ischemic Stroke Patients with acute ischemic stroke admitted within 12 hours after onset.

Outcome Measures

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. [Within 12 hours after ischemic stroke onset.]