Myocardial Damage In Patients With Cerebral Infarction

This study has been completed.
Sponsor:
Collaborators:
Fonden for Lægevidenskabelig Forskning for Fyns Amt.
Novo Nordisk A/S
AJ Andersen og Hustrus Fond
Overlægerådet Legatudvalg
Raimond and Dagmar Ringgård-Bohn's Foundation
Bankdirektør Hans Stener og hustru Agnes Steners legat
Odense University Hospital
Information provided by:
Danish Heart Foundation
ClinicalTrials.gov Identifier:
NCT00306579
First received: March 23, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
  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 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 A/S
AJ Andersen og Hustrus Fond
Overlægerådet Legatudvalg
Raimond and Dagmar Ringgård-Bohn's Foundation
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

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

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

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

ClinicalTrials.gov processed this record on October 23, 2014