Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354406
Status:
COMPLETED
Last Update Posted:
2011-11-16
First Post:
2006-07-19
Brief Title:
Efficacy Study on Early Versus Late Abciximab Administration During Primary Coronary Angioplasty
Sponsor:
University of Pisa
Organization:
University of Pisa
Study Overview
Official Title:
A Randomized Trial Comparing the Efficacy on Myocardial Infarct Size Reduction of Early vs Late Abciximab Administration During Primary Percutaneous Coronary Angioplasty
Status:
COMPLETED
Status Verified Date:
2011-11
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:
Abciximab has been demonstrated to improve outcome when administered during primary angioplasty in patients with acute myocardial infarction The Primary Objective of the study is to demonstrate that early before transportation form remote hospital to the cath lab abciximab administration during acute myocardial infarction reduces infarct size as compared with late just prior to PCI abciximab administration as measured by delayed enhancement magnetic resonance MR at 6 months
Detailed Description:
Strategies directed at improving myocardial perfusion or viability in the setting of acute myocardial infarction AMI are currently suboptimal The consequences of microvascular damage as assessed by the TIMI myocardial perfusion TMP grade or by cardiac magnetic resonance imaging MR are serious and affect survival after AMI Because the size of the infarct is an important predictor of prognosis precise determination of infarct size allows risk stratification of patients after AMI
First-pass MR perfusion studies recently developed provide quantification of the absolute measure of myocardial blood flow as well as direct visualization of myocardial perfusion abnormalities such as areas of no-reflow The hyperenhancement technique Delayed enhancement identifies viable and nonviable myocardium as well as no-reflow areas
A recent pilot study showed that infarct size measured by scintigraphy at 7 days was 23 vs 14 when abciximab was administered in the cath lab vs emergency room with a reduction in infarct size of 40
The present study will be conducted at the Cardiothoracic Department of the University of Pisa together with the Institute of Clinical Physiology CNR and two other Cath Labs of the West of Tuscany Each Cath Lab will treat patients enrolled in peripheral hospitals referring the patients for primary PCI
The primary objective of the study is to demonstrate that early abciximab administration before transfer as compared with late abciximab administration in the Cath Lab reduces infarct size as measured by delayed hyperenhancement imaging at 6 months
The major secondary objectives of this substudy are to demonstrate that early abciximab administration
1 Improves angiographic TMP grade and cTFC compared with primary PCI group immediately after PCI
2 Reduces the extension of no-reflow areas as assessed by DE-MRI before discharge
3 Reduces the extension of microvasculature damage as assessed by fist-pass perfusion study by MRI before discharge
4 Improves regional wall motion and left ventricular ejection fraction LVEF as measured by cine MR and 2D echocardiography at 6 months
5 Reduces the occurrence of LV remodeling at 6 month follow up
First-pass MR perfusion studies recently developed provide quantification of the absolute measure of myocardial blood flow as well as direct visualization of myocardial perfusion abnormalities such as areas of no-reflow The hyperenhancement technique Delayed enhancement identifies viable and nonviable myocardium as well as no-reflow areas
A recent pilot study showed that infarct size measured by scintigraphy at 7 days was 23 vs 14 when abciximab was administered in the cath lab vs emergency room with a reduction in infarct size of 40
The present study will be conducted at the Cardiothoracic Department of the University of Pisa together with the Institute of Clinical Physiology CNR and two other Cath Labs of the West of Tuscany Each Cath Lab will treat patients enrolled in peripheral hospitals referring the patients for primary PCI
The primary objective of the study is to demonstrate that early abciximab administration before transfer as compared with late abciximab administration in the Cath Lab reduces infarct size as measured by delayed hyperenhancement imaging at 6 months
The major secondary objectives of this substudy are to demonstrate that early abciximab administration
1 Improves angiographic TMP grade and cTFC compared with primary PCI group immediately after PCI
2 Reduces the extension of no-reflow areas as assessed by DE-MRI before discharge
3 Reduces the extension of microvasculature damage as assessed by fist-pass perfusion study by MRI before discharge
4 Improves regional wall motion and left ventricular ejection fraction LVEF as measured by cine MR and 2D echocardiography at 6 months
5 Reduces the occurrence of LV remodeling at 6 month follow up
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