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Sponsors and Collaborators: |
University of Pisa Eli Lilly and Company |
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Information provided by: | University of Pisa |
ClinicalTrials.gov Identifier: | NCT00354406 |
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.
Condition | Intervention | Phase |
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Myocardial Infarction |
Drug: abciximab |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Trial Comparing the Efficacy on Myocardial Infarct Size Reduction of Early Vs. Late Abciximab Administration During Primary Percutaneous Coronary Angioplasty |
Estimated Enrollment: | 100 |
Study Start Date: | April 2006 |
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 meausured 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 toghether 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:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anna S Petronio, MD | +39050995321 | a.petronio@ao-pisa.toscana.it |
Contact: Marco De Carlo, MD, PhD | +39050995231 | marcodecarlo@gmail.com |
Italy | |
Cardiothoracic Department, Ospedale Cisanello | Recruiting |
Pisa, Italy, 56124 |
Principal Investigator: | Anna S Petronio, MD | University of Pisa |
Study ID Numbers: | UP-DCT-200601 |
Study First Received: | July 19, 2006 |
Last Updated: | July 19, 2006 |
ClinicalTrials.gov Identifier: | NCT00354406 |
Health Authority: | Italy: Ministry of Health |
Abciximab Magnetic Resonance Imaging Percutaneous Transluminal Coronary Angioplasty |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Abciximab Ischemia Infarction Myocardial Infarction |
Anticoagulants Pathologic Processes Therapeutic Uses Hematologic Agents |
Platelet Aggregation Inhibitors Cardiovascular Diseases Pharmacologic Actions |