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Completed

NCT Number: NCT00306579

Myocardial Damage In Patients With Cerebral Infarction

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute ischemic stroke.
  • Age ≥ 18 years old.
  • Written, informed consent.

Exclusion criteria

  • Onset of stroke symptoms 8 to 21 days before admission.
  • Transient ischemic attack.
  • Intracerebral or subarachnoid haemorrhage.
  • Previous myocardial infarction.
  • Any pathological Q waves on the baseline ECG.
  • Current atrial fibrillation.
  • Unstable angina pectoris ≤ 3 weeks before admission.
  • Systolic blood pressure ≤ 90 mmHg and symptoms.
  • Resuscitation after cardiac arrest.
  • Unwillingness to participate.

Sponsors and collaborators

Lead sponsor

Danish Heart Foundation

Other

Collaborators

  • AJ Andersen og Hustrus Fond
  • Bankdirektør Hans Stener og hustru Agnes Steners legat
  • Fonden for Lægevidenskabelig Forskning for Fyns Amt.
  • Novo Nordisk A/S
  • Odense University Hospital
  • Overlægerådet Legatudvalg
  • Raimond and Dagmar Ringgård-Bohn's Foundation

Registry information

Official study title

Myocardial Damage In Patients With Cerebral Infarction. Prevalence and Characteristics as Measured by Troponins, Electrocardiographic Changes and Myocardial Perfusion Imaging.

Important dates

Study start
2003
Study completion
2005
First posted
Mar 24, 2006
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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