Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260416
Status:
COMPLETED
Last Update Posted:
2008-05-22
First Post:
2005-11-30
Brief Title:
Primary Angioplasty for Acute Myocardial Infarction in Patients With Symptom Duration Above 12 Hours
Sponsor:
Aarhus University Hospital Skejby
Organization:
Aarhus University Hospital Skejby
Study Overview
Official Title:
Primary Angioplasty for Acute Myocardial Infarction in Patients With Symptom Duration Above 12 Hours
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 iv 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None