Clinical trial NCT00306579: Myocardial Damage In Patients With Cerebral Infarction
Official title: Myocardial Damage In Patients With Cerebral Infarction. Prevalence and Characteristics as Measured by Troponins, Electrocardiographic Changes and Myocardial Perfusion Imaging.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Keywords: Ischemic Stroke
Myocardial ischemia
Myocardial necrosis
Lead sponsor: Danish Heart Foundation
Sponsor class: OTHER
Collaborators: name: Fonden for Lægevidenskabelig Forskning for Fyns Amt.
name: Novo Nordisk A/S
name: AJ Andersen og Hustrus Fond
name: Overlægerådet Legatudvalg
name: Raimond and Dagmar Ringgård-Bohn's Foundation
name: Bankdirektør Hans Stener og hustru Agnes Steners legat
name: Odense University Hospital
First posted: 2006-03-24
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief 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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Cardiology, Odense University Hospital
name: Jesper K. Jensen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, Odense University Hospital
name: Hans Mickley, DMSci
role: STUDY_DIRECTOR
affiliation: Department of Neurology, Odense University Hospital
name: Søren Bak, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Nuclear Medicine, Odense University Hospital
name: Poul Flemming H. Carlsen, DMSci
role: STUDY_CHAIR
affiliation: Department of Clinical Chemistry, Aalborg Hospital
name: Søren R. Kristensen, DMSci
role: STUDY_CHAIR
References: