- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00288210
Sirolimus Eluting Stenting in Acute Myocardial Infarction
Randomized Study Of Sirolimus Eluting Stent Vs Conventional Stent In Acute Myocardial Infarction Acronym SESAMI
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
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Roma, Italy, 00100
- Cardiologia Interventistica Ospedale San Camillo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
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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.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary end point for the trial was the binary restonis at one year angiographic follow-up
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Secondary Outcome Measures
Outcome Measure |
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Secondary end points included a composite of
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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
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Roberto Violini, MD, Cardiologia Interventistica Ospedale San Camillo Roma
- Principal Investigator: Maurizio Menichelli, MD, Cardiologia Interventistica Ospedale San Camillo Roma
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 183/2003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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