Primary Angioplasty for Acute Myocardial Infarction in Patients With Symptom Duration Above 12 Hours
May 21, 2008 updated by: Aarhus University Hospital Skejby
Background: Acute balloon angioplasty is beneficial in patients with acute myocardial infarction. However, presently this treatment is not offered to patients with symptom duration above 12 hours.
Hypothesis: Acute balloon angioplasty for myocardial infarction is beneficial despite symptom duration above 12 hours.
Methods: In 60 patients with myocardial infarction and symptom duration above 12 hours, the proportion of non-perfused myocardium before acute angioplasty and 1 month after angioplasty is compared to evaluate if myocardial tissue can be saved by acute angioplasty despite long symptom duration.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Methods: On arrival at our angioplasty laboratory, patients are informed about the study.
If they accept to participate, we infuse 600 MBq of Sestamibi i.v.
This binds in a first passage fashion without later redistribution to perfused myocardium.
Non-perfused myocardium does not bind sestamibi.
Primary angioplasty with stent and abciximab is then performed followed by myocardial scintigraphy to illustrate the non-perfused myocardial area that was at risk of infarction before the coronary artery was opened.
Echocardiography is also performed.
At 1 month, myocardial scintigraphy is repeated to evaluate infarct size.
The difference between the myocardial area at risk of infarction before angioplasty and the myocardial infarct size 1 month later is defined as "salvage".
Scintigraphy is repeated at 6 month and echocardiography is also repeated at 1 month and 6 months.
The primary endpoint is "salvage".
Accordingly, the aim is to demonstrate that salvage can be achieved with primary angioplasty for acute myocardial infarction despite symptom duration above 12 hours.
Clinical endpoints are death and reinfarction.
The results are compared with results in 200 patients with symptom duration below 12 hours.
These patients are treated and examined according to the exact same protocol.
By this comparison, it can be evaluated whether it is relevant that the current guidelines recommend acute balloon angioplasty only to patients with less than 12 hours of symptom duration.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aarhus, Denmark, DK-8200 N
- Departments of Cardiology and Nuclear Medicine at Skejby Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- Acute myocardial infarction with ST-segment elevation;
- Symptom duration 12 hours to 72 hours.
Exclusion Criteria:
- Age below 18 years;
- Bleeding disorders or anaemia or low levels of thrombocytes;
- Thrombolysis used during the present admission;
- Expected survival less than 1 year due to other diseases;
- Previous acute myocardial infarction or coronary by-pass surgery;
- Major operation within last 30 days;
- Heamorrhaghic stroke within last 3 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Myocardial salvage as evaluated by repeat myocardial scintigraphy(= area at risk of infarction before primary angioplasty - infarct size at 1 month).
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Secondary Outcome Measures
Outcome Measure |
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Infarct size by myocardial scintigraphy at 1 month and 6 months after primary angioplasty.
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Death at 1 month and 6 months.
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Reinfarction at 1 month and 6 months.
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Ejection fraction at 1 day, 1 month and 6 months.
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Left ventricular end diastolic volume at 1 day, 1 month and 6 months.
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Brain Natriuretic Peptide levels at 1 day, 1 month and 6 months.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Steen D. Kristensen, MD, Dept. of Cardiology, Skejby Hospital, AarhusUniversity Hospital, DK-8200 Aarhus N, Denmark, Europe
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
November 30, 2005
First Submitted That Met QC Criteria
November 30, 2005
First Posted (Estimate)
December 1, 2005
Study Record Updates
Last Update Posted (Estimate)
May 22, 2008
Last Update Submitted That Met QC Criteria
May 21, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STEMI-12
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