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Primary Angioplasty for Acute Myocardial Infarction in Patients With Symptom Duration Above 12 Hours

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Primary angioplasty with stent and abciximab
Sponsored by
Aarhus University Hospital Skejby
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Acute myocardial infarction, Symptom duration, Primary angioplasty, Infarct size, Myocardial scintigraphy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Departments of Cardiology and Nuclear Medicine at Skejby Hospital

Outcomes

Primary Outcome Measures

Myocardial salvage as evaluated by repeat myocardial scintigraphy(= area at risk of infarction before primary angioplasty - infarct size at 1 month).

Secondary Outcome Measures

Infarct size by myocardial scintigraphy at 1 month and 6 months after primary angioplasty.
Death at 1 month and 6 months.
Reinfarction at 1 month and 6 months.
Ejection fraction at 1 day, 1 month and 6 months.
Left ventricular end diastolic volume at 1 day, 1 month and 6 months.
Brain Natriuretic Peptide levels at 1 day, 1 month and 6 months.

Full Information

First Posted
November 30, 2005
Last Updated
May 21, 2008
Sponsor
Aarhus University Hospital Skejby
Collaborators
Danish Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00260416
Brief Title
Primary Angioplasty for Acute Myocardial Infarction in Patients With Symptom Duration Above 12 Hours
Official Title
Primary Angioplasty for Acute Myocardial Infarction in Patients With Symptom Duration Above 12 Hours
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Aarhus University Hospital Skejby
Collaborators
Danish Heart Foundation

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Acute myocardial infarction, Symptom duration, Primary angioplasty, Infarct size, Myocardial scintigraphy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Primary angioplasty with stent and abciximab
Primary Outcome Measure Information:
Title
Myocardial salvage as evaluated by repeat myocardial scintigraphy(= area at risk of infarction before primary angioplasty - infarct size at 1 month).
Secondary Outcome Measure Information:
Title
Infarct size by myocardial scintigraphy at 1 month and 6 months after primary angioplasty.
Title
Death at 1 month and 6 months.
Title
Reinfarction at 1 month and 6 months.
Title
Ejection fraction at 1 day, 1 month and 6 months.
Title
Left ventricular end diastolic volume at 1 day, 1 month and 6 months.
Title
Brain Natriuretic Peptide levels at 1 day, 1 month and 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steen D. Kristensen, MD
Organizational Affiliation
Dept. of Cardiology, Skejby Hospital, AarhusUniversity Hospital, DK-8200 Aarhus N, Denmark, Europe
Official's Role
Study Director
Facility Information:
Facility Name
Departments of Cardiology and Nuclear Medicine at Skejby Hospital
City
Aarhus
ZIP/Postal Code
DK-8200 N
Country
Denmark

12. IPD Sharing Statement

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Primary Angioplasty for Acute Myocardial Infarction in Patients With Symptom Duration Above 12 Hours

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