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Myocardial Damage In Patients With Cerebral Infarction
This study has been completed.
First Received: March 23, 2006   No Changes Posted
Sponsors and Collaborators: Danish Heart Foundation
Fonden for Lægevidenskabelig Forskning for Fyns Amt.
Novo Nordisk
AJ Andersen og Hustrus Fond
Overlægerådet Legatudvalg
Raimond og Dagmar Ringgård Bohns Fond
Bankdirektør Hans Stener og hustru Agnes Steners legat
Odense University Hospital
Information provided by: Danish Heart Foundation
ClinicalTrials.gov Identifier: NCT00306579
  Purpose

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.


Condition Phase
Ischemic Stroke
Phase IV

Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Prospective Study
Official Title: Myocardial Damage In Patients With Cerebral Infarction. Prevalence and Characteristics as Measured by Troponins, Electrocardiographic Changes and Myocardial Perfusion Imaging.

Further study details as provided by Danish Heart Foundation:

Estimated Enrollment: 250
Study Start Date: August 2003
Estimated Study Completion Date: May 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Acute ischemic stroke.
  2. Age ≥ 18 years old.
  3. Written, informed consent.

Exclusion Criteria:

  1. Onset of stroke symptoms 8 to 21 days before admission.
  2. Transient ischemic attack.
  3. Intracerebral or subarachnoid haemorrhage.
  4. Previous myocardial infarction.
  5. Any pathological Q waves on the baseline ECG.
  6. Current atrial fibrillation.
  7. Unstable angina pectoris ≤ 3 weeks before admission.
  8. Systolic blood pressure ≤ 90 mmHg and symptoms.
  9. Resuscitation after cardiac arrest.
  10. Unwillingness to participate.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00306579

Sponsors and Collaborators
Danish Heart Foundation
Fonden for Lægevidenskabelig Forskning for Fyns Amt.
Novo Nordisk
AJ Andersen og Hustrus Fond
Overlægerådet Legatudvalg
Raimond og Dagmar Ringgård Bohns Fond
Bankdirektør Hans Stener og hustru Agnes Steners legat
Odense University Hospital
Investigators
Principal Investigator: Jesper K. Jensen, MD Department of Cardiology, Odense University Hospital
Study Director: Hans Mickley, DMSci Department of Cardiology, Odense University Hospital
Study Chair: Søren Bak, MD, PhD Department of Neurology, Odense University Hospital
Study Chair: Poul Flemming H. Carlsen, DMSci Department of Nuclear Medicine, Odense University Hospital
Study Chair: Søren R. Kristensen, DMSci Department of Clinical Chemistry, Aalborg Hospital
  More Information

No publications provided

Study ID Numbers: 054B26A43722225
Study First Received: March 23, 2006
Last Updated: March 23, 2006
ClinicalTrials.gov Identifier: NCT00306579     History of Changes
Health Authority: Denmark: National Board of Health

Keywords provided by Danish Heart Foundation:
Ischemic Stroke
Myocardial ischemia
Myocardial necrosis

Study placed in the following topic categories:
Necrosis
Cerebral Infarction
Myocardial Ischemia
Stroke
Vascular Diseases
Central Nervous System Diseases
Brain Ischemia
Brain Infarction
Ischemia
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases
Cerebrovascular Disorders
Necrosis
Pathologic Processes
Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Infarction

ClinicalTrials.gov processed this record on September 11, 2009