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Sirolimus Eluting Stenting in Acute Myocardial Infarction

Primary Purpose

Myocardial Infarction

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Primary angioplasty in acute myocardial infarction
Sponsored by
San Camillo Hospital, Rome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial Infarction, Stents, Sirolimus, abciximab

Eligibility Criteria

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

Inclusion Criteria: Inclusion criteria were an age of more than 18 years, the presence for at least 30 minutes but less than 12 hours of symptoms consistent with acute myocardial infarction, and the presence of ST-segment elevation in at least two contiguous leads or left bundle-branch block. - Exclusion Criteria: Patients were excluded if they were in cardiogenic shock (defined as systolic blood pressure of less than 80 mm Hg for more than 30 minutes or the need for intravenous pressors or intraaortic-balloon counterpulsation); had a history of bleeding diathesis; had a history of leukopenia, thrombocytopenia, or severe hepatic or renal dysfunction; had a noncardiac illness associated with a life expectancy of less than one year; were participating in another study; or were unable to give informed consent owing to prolonged cardiopulmonary resuscitation. -

Sites / Locations

  • Cardiologia Interventistica Ospedale San Camillo

Outcomes

Primary Outcome Measures

The primary end point for the trial was the binary restonis at one year angiographic follow-up

Secondary Outcome Measures

Secondary end points included a composite of
MACE including death, Q-wave and non-Q-wave infarction, emergent bypass surgery, or repeat TLR at 30 days and 12 months after the index procedure

Full Information

First Posted
February 6, 2006
Last Updated
February 9, 2006
Sponsor
San Camillo Hospital, Rome
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1. Study Identification

Unique Protocol Identification Number
NCT00288210
Brief Title
Sirolimus Eluting Stenting in Acute Myocardial Infarction
Official Title
Randomized Study Of Sirolimus Eluting Stent Vs Conventional Stent In Acute Myocardial Infarction Acronym SESAMI
Study Type
Interventional

2. Study Status

Record Verification Date
February 2006
Overall Recruitment Status
Unknown status
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
San Camillo Hospital, Rome

4. Oversight

5. Study Description

Brief Summary
The incidence of stent restenosis in the setting of primary angioplasty is particularly high, reaching a rate of 27% In the last years the introduction of drug-eluting stents has drastically reduced the incidence of restenosis in patients not requiring urgent revascularization. Whether drug-eluting stenting might constitute the new optimal therapy for patients with an acute myocardial infarction is unknown. To be able to answer this question, we designed a randomized trial in which patients with an acute myocardial infarction eligible for treatment with primary angioplasty and abciximab were randomized to receive either a rapamicine-eluting stent or a conventional bare stent.
Detailed Description
The treatment of acute myocardial infarction has evolved dramatically in the last decade. Coronary angioplasty with stent implantation in conjunction with an optimal antitrombotic therapy as abciximab is now considered current standard therapy However, the incidence of stent restenosis in the setting of primary angioplasty remains particularly high, reaching a rate of 27%. A high restenosis rate causes a high re-hospitalization rate for target vessel revascularization and an ensuing increase in cost.In the last years the introduction of drug-eluting stents has drastically reduced the incidence of restenosis in patients not requiring urgent revascularization. This reduced incidence of restenosis occurs without an increase in adverse clinical events over conventional stents and has a very low rate of stent subacute thrombosis. Whether this combination of drug-eluting stents and abciximab might constitute the new optimal therapy for patients with an acute myocardial infarction is unknown. To be able to answer this question, we designed a one year coronary angiographic study in which patients with an acute myocardial infarction eligible for treatment with primary angioplasty and abciximab were randomized to receive either a rapamicine-eluting stent or a conventional bare stent.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Myocardial Infarction, Stents, Sirolimus, abciximab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Primary angioplasty in acute myocardial infarction
Primary Outcome Measure Information:
Title
The primary end point for the trial was the binary restonis at one year angiographic follow-up
Secondary Outcome Measure Information:
Title
Secondary end points included a composite of
Title
MACE including death, Q-wave and non-Q-wave infarction, emergent bypass surgery, or repeat TLR at 30 days and 12 months after the index procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria were an age of more than 18 years, the presence for at least 30 minutes but less than 12 hours of symptoms consistent with acute myocardial infarction, and the presence of ST-segment elevation in at least two contiguous leads or left bundle-branch block. - Exclusion Criteria: Patients were excluded if they were in cardiogenic shock (defined as systolic blood pressure of less than 80 mm Hg for more than 30 minutes or the need for intravenous pressors or intraaortic-balloon counterpulsation); had a history of bleeding diathesis; had a history of leukopenia, thrombocytopenia, or severe hepatic or renal dysfunction; had a noncardiac illness associated with a life expectancy of less than one year; were participating in another study; or were unable to give informed consent owing to prolonged cardiopulmonary resuscitation. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Violini, MD
Organizational Affiliation
Cardiologia Interventistica Ospedale San Camillo Roma
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maurizio Menichelli, MD
Organizational Affiliation
Cardiologia Interventistica Ospedale San Camillo Roma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiologia Interventistica Ospedale San Camillo
City
Roma
ZIP/Postal Code
00100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
17498576
Citation
Menichelli M, Parma A, Pucci E, Fiorilli R, De Felice F, Nazzaro M, Giulivi A, Alborino D, Azzellino A, Violini R. Randomized trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction (SESAMI). J Am Coll Cardiol. 2007 May 15;49(19):1924-30. doi: 10.1016/j.jacc.2007.01.081. Epub 2007 Apr 30.
Results Reference
derived

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Sirolimus Eluting Stenting in Acute Myocardial Infarction

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