NCT00306579

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. 1.The prevalence and characteristics of ECG changes suggestive of myocardial ischemia.
  2. 2.The prevalence of transient ST-segment changes on ambulatory monitoring.
  3. 3.The prevalence and degree of myocardial necrosis as judged from biochemical markers.
  4. 4.The prevalence of reversible and irreversible perfusion defects on myocardial scintigraphy.
  5. 5.The prevalence, size and patterns of NT-proBNP.
  6. 6.Whether there is a change in ECG and biochemical markers over a 6-month follow-up period.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2006

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

First QC Date

March 23, 2006

Last Update Submit

August 7, 2017

Conditions

Ischemic Stroke

Keywords

Ischemic StrokeMyocardial ischemiaMyocardial necrosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute ischemic stroke.
  • Age ≥ 18 years old.
  • Written, informed consent.

You may not qualify if:

  • Onset of stroke symptoms 8 to 21 days before admission.
  • Transient ischemic attack.
  • Intracerebral or subarachnoid haemorrhage.
  • Previous myocardial infarction.
  • Any pathological Q waves on the baseline ECG.
  • Current atrial fibrillation.
  • Unstable angina pectoris ≤ 3 weeks before admission.
  • Systolic blood pressure ≤ 90 mmHg and symptoms.
  • Resuscitation after cardiac arrest.
  • Unwillingness to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ischemic StrokeMyocardial IschemiaMyocardial Infarction

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHeart DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Jesper K. Jensen, MD

    Department of Cardiology, Odense University Hospital

    PRINCIPAL INVESTIGATOR

  • Hans Mickley, DMSci

    Department of Cardiology, Odense University Hospital

    STUDY DIRECTOR

  • 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 CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2006

First Posted

March 24, 2006

Study Start

August 1, 2003

Study Completion

May 1, 2005

Last Updated

August 8, 2017

Record last verified: 2017-08