Ischemic StrokeNCT00306579
Myocardial Damage In Patients With Cerebral Infarction
An observational study of Ischemic Stroke, run by Danish Heart Foundation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to May 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute ischemic stroke.
- Age ≥ 18 years old.
- Written, informed consent.
Who cannot join
- 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.
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- Unstable angina pectoris ≤ 3 weeks before admission.
- Systolic blood pressure ≤ 90 mmHg and symptoms.
- Resuscitation after cardiac arrest.
- Unwillingness to participate.
About this study
Official title: 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.
Read more
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:
- The prevalence and characteristics of ECG changes suggestive of myocardial ischemia.
- The prevalence of transient ST-segment changes on ambulatory monitoring.
- The prevalence and degree of myocardial necrosis as judged from biochemical markers.
- The prevalence of reversible and irreversible perfusion defects on myocardial scintigraphy.
- The prevalence, size and patterns of NT-proBNP.
- 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
- Keywords
- Ischemic Stroke, Myocardial ischemia, Myocardial necrosis
- Medical subject headings
- Ischemic Stroke, Myocardial Ischemia, Myocardial Infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2006 (estimated)
- Study startAug 2003
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Danish Heart Foundation
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Jesper K. Jensen, MD, Principal investigator, Department of Cardiology, Odense University HospitalHans Mickley, DMSci, Study director, Department of Cardiology, Odense University HospitalSøren Bak, MD, PhD, Study chair, Department of Neurology, Odense University HospitalPoul Flemming H. Carlsen, DMSci, Study chair, Department of Nuclear Medicine, Odense University HospitalSøren R. Kristensen, DMSci, Study chair, Department of Clinical Chemistry, Aalborg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306579
- Sponsor's protocol ID
- 054B26A43722225
- Status last verified
- Aug 2017
- First submitted
- 23 Mar 2006
- Last updated
- 8 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Damage In Patients With Cerebral Infarction. Prevalence and Characteristics as Measured by Troponins, Electrocardiographic Changes and Myocardial Perfusion Imaging.
- ClinicalTrials.gov ID
- NCT00306579
- Acronym / sponsor ID
- 054B26A43722225
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic Stroke, Myocardial ischemia, Myocardial necrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- Danish Heart FoundationUniversity, hospital or other
- 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
- Study start
- Aug 2003
- Study completion
- May 2005
- First posted
- 24 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The prevalence and characteristics of ECG changes suggestive of myocardial ischemia.
- The prevalence of transient ST-segment changes on ambulatory monitoring.
- The prevalence and degree of myocardial necrosis as judged from biochemical markers.
- The prevalence of reversible and irreversible perfusion defects on myocardial scintigraphy.
- The prevalence, size and patterns of NT-proBNP.
- 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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute ischemic stroke.
- Age ≥ 18 years old.
- Written, informed consent.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesper K. Jensen, MD principal investigator
Department of Cardiology, Odense University Hospital
Hans Mickley, DMSci study director
Department of Cardiology, Odense University Hospital
Søren Bak, MD, PhD study chair
Department of Neurology, Odense University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Danish Heart Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.