Myocardial Damage In Patients With Cerebral Infarction

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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke

• Study Type: Observational
• Enrollment: 250

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: August 1, 2003
• Primary Completion: December 7, 2022
• Study Completion: May 1, 2005

Study Registration Dates

• First Submitted: March 23, 2006
• First Submitted That Met QC Criteria: March 23, 2006
• First Posted (Estimate): March 24, 2006

Study Record Updates

• Last Update Posted (Actual): August 8, 2017
• Last Update Submitted That Met QC Criteria: August 7, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Ischemic Stroke; Myocardial ischemia; Myocardial necrosis
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Brain Infarction; Infarction; Ischemic Stroke; Cerebral Infarction
• Other Study ID Numbers: 054B26A43722225

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No