Myocardial Damage In Patients With Cerebral Infarction

NCT00306579 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2017-08-08

No results posted yet for this study

Summary

Introduction

For several years "ischemic" electrocardiographic (ECG) changes in the acute phase of ischemic stroke have been reported. Whether these ECG changes reflect true myocardial ischemia remains controversial. So far no study has assessed different markers of myocardial ischemia or necrosis in consecutive patients admitted to hospital with an acute ischemic stroke.

Purpose

The main purpose of this study is to determine the potential burden of reversible and irreversible myocardial ischemia in patients with an acute ischemic stroke.

Patients and methods

Serial blood samples for measuring troponin T, CK-MB and NT-proBNP are collected in 250 patients with evidence of an acute ischemic stroke admitted to the Department of Neurology at Odense University Hospital. In addition resting 12-lead ECG recordings will be obtained on a daily basis, and a 24-hour ST-segment ambulatory monitoring will be performed once within the first week of hospitalisation. Finally, myocardial perfusion patterns during rest will be evaluated by means of a myocardial perfusion scintigraphy in patients with an elevated troponin T level.

Six months later control measurements of troponin T, CK-MB and NT-proBNP and a 12-lead ECG will be obtained.

Expectations

The study will contribute with original observations in patients with acute ischemic stroke considering the following issues:

1. The prevalence and characteristics of ECG changes suggestive of myocardial ischemia.
2. The prevalence of transient ST-segment changes on ambulatory monitoring.
3. The prevalence and degree of myocardial necrosis as judged from biochemical markers.
4. The prevalence of reversible and irreversible perfusion defects on myocardial scintigraphy.
5. The prevalence, size and patterns of NT-proBNP.
6. Whether there is a change in ECG and biochemical markers over a 6-month follow-up period.

The results may have clinical implications regarding early and late treatment as well as clinical follow-up of patients recovering from an episode of acute ischemic stroke.

Conditions

Sponsors & Collaborators

  • Fonden for Lægevidenskabelig Forskning for Fyns Amt.

    collaborator UNKNOWN
  • Novo Nordisk A/S

    collaborator INDUSTRY
  • AJ Andersen og Hustrus Fond

    collaborator OTHER
  • Overlægerådet Legatudvalg

    collaborator UNKNOWN
  • Raimond and Dagmar Ringgård-Bohn's Foundation

    collaborator OTHER
  • Bankdirektør Hans Stener og hustru Agnes Steners legat

    collaborator UNKNOWN
  • Odense University Hospital

    collaborator OTHER
  • Danish Heart Foundation

    lead OTHER

Principal Investigators

  • Jesper K. Jensen, MD · Department of Cardiology, Odense University Hospital

  • Hans Mickley, DMSci · Department of Cardiology, Odense University Hospital

  • Søren Bak, MD, PhD · Department of Neurology, Odense University Hospital

  • Poul Flemming H. Carlsen, DMSci · Department of Nuclear Medicine, Odense University Hospital

  • Søren R. Kristensen, DMSci · Department of Clinical Chemistry, Aalborg Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Completion
2005-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00306579 on ClinicalTrials.gov