Myocardial Damage In Patients With Cerebral Infarction

NCT ID: NCT00306579

Last Updated: 2017-08-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2005-05-31

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.

Conditions

Ischemic Stroke

Study Design

• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fonden for Lægevidenskabelig Forskning for Fyns Amt.

UNKNOWN

Sponsor Role: collaborator

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

AJ Andersen og Hustrus Fond

OTHER

Sponsor Role: collaborator

Overlægerådet Legatudvalg

UNKNOWN

Sponsor Role: collaborator

Raimond and Dagmar Ringgård-Bohn's Foundation

OTHER

Sponsor Role: collaborator

Bankdirektør Hans Stener og hustru Agnes Steners legat

UNKNOWN

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: collaborator

Danish Heart Foundation

OTHER

Sponsor Role: lead

Principal Investigators

Jesper K. Jensen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Odense University Hospital

Hans Mickley, DMSci

Role: STUDY_DIRECTOR

Department of Cardiology, Odense University Hospital

Søren Bak, MD, PhD

Role: STUDY_CHAIR

Department of Neurology, Odense University Hospital

Poul Flemming H. Carlsen, DMSci

Role: STUDY_CHAIR

Department of Nuclear Medicine, Odense University Hospital

Søren R. Kristensen, DMSci

Role: STUDY_CHAIR

Department of Clinical Chemistry, Aalborg Hospital

Other Identifiers

054B26A43722225

Identifier Type: -

Identifier Source: org_study_id