Heart and Ischemic STrOke Relationship studY (HISTORY)

October 31, 2017 updated by: Michal Kral, University Hospital Olomouc

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:

  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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Olomouc, Czechia, 775 20
        • Recruiting
        • University Hospital Olomouc
        • Contact:
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Acute Ischemic Stroke
Patients with acute ischemic stroke admitted within 12 hours after onset.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Within 12 hours after ischemic stroke onset.

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between location and volume of brain infarction.
Time Frame: At admission within 12 hours after stroke onset and after 24hours.
At admission within 12 hours after stroke onset and after 24hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Olomouc

Collaborators

Palacky University
Ministry of Health, Czech Republic

Investigators

  • Study Director: Michal Kral, MD, University Hospital Olomouc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

February 23, 2012

First Submitted That Met QC Criteria

February 28, 2012

First Posted (Estimate)

February 29, 2012

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

October 31, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NT 11046-6/2010
  • Grant project No.86-17 (Other Identifier: University Hospital Olomouc)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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