Sirolimus Eluting Stenting in Acute Myocardial Infarction

NCT00288210 | Unknown Phase 4

• 1 other identifier: 183/2003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

Myocardial Infarction; Stents; Sirolimus; abciximab

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• 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

Interventions

Primary angioplasty in acute myocardial infarction PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Camillo Hospital, Rome: lead

Study Sites (1)

Cardiologia Interventistica Ospedale San Camillo

Roma, Roma, 00100, Italy

Location

Related Publications (1)

• 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.

  PMID: 17498576 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Roberto Violini, MD

  Cardiologia Interventistica Ospedale San Camillo Roma

  STUDY CHAIR

• Maurizio Menichelli, MD

  Cardiologia Interventistica Ospedale San Camillo Roma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Study Start: March 1, 2003
• Study Completion: March 1, 2006
• Last Updated: February 10, 2006

Record last verified: 2006-02

Locations

IT (1)