Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction (NSTEMI) Patients: One Stage Versus Multistaged Percutaneous Coronary Intervention (PCI) (SMILE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Roma La Sapienza.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Gennaro Sardella, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01478984
First received: November 11, 2011
Last updated: November 21, 2011
Last verified: November 2011
  Purpose

Patients with NSTEMI and multivessel disease will be scheduled to undergo early invasive strategy (PCI within 72 hours) of de novo native coronary artery lesions were considered for recruitment into the study. Inclusion criteria are the following: diagnosis of NSTEMI according to current guidelines presenting with multivessel disease. We will exclude patients with cardiogenic shock at presentation (systolic blood pressure <90 mmHg despite drug therapy), left main coronary disease (>50% diameter stenosis), previous coronary artery bypass grafting (CABG) surgery, patients with Syntax Score >32 and candidated to by-pass surgery (10), severe valvular heart disease and unsuccessful procedures. Procedure success was defined as the achievement of an angiographic residual stenosis of less than 30% and a thrombolysis in myocardial infarction (TIMI) flow grade III after PCI.

Patients randomized to One-Stage group were completely revascularizated in one time PCI, whereas patients randomized to Multi-Staged group were completely revascularizated in more time PCI, during the same hospitalization. Patients received a clopidogrel loading dose of 600 mg before the PCI (for loading dose administered more than 6 h prior to procedure). Post-procedural antiplatelet regimen consisted of aspirin at 100 mg/day indefinitely and clopidogrel 75 mg/day for at least one month.


Condition Intervention Phase
Non ST Segment Elevation MI and Unstable Angina
Procedure: One-Stage group
Procedure: Multi-Staged group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of One Stage Compared With Multistaged PCI Complete Revascularization on Clinical Outcome in Multivessel NSTEMI Patients. Smile Trial

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Major Adverese Cardiac and cerebral Events (MACCE) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Incidence of major adverse cardiac and cerebrovascular events (MACCE) defined as cardiac or non-cardiac death, inhospital death, re-infarction, re-hospitalisation for acute coronary syndrome, repeat coronary revascularization and stroke at 30 days, 6 months and 1 year.

  • Major Adverese Cardiac and cerebral Events (MACCE) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Incidence of major adverse cardiac and cerebrovascular events (MACCE) defined as cardiac or non-cardiac death, inhospital death, re-infarction, re-hospitalisation for acute coronary syndrome, repeat coronary revascularization and stroke at 30 days, 6 months and 1 year.

  • MACCE [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Incidence of major adverse cardiac and cerebrovascular events (MACCE) defined as cardiac or non-cardiac death, inhospital death, re-infarction, re-hospitalisation for acute coronary syndrome, repeat coronary revascularization and stroke at 30 days, 6 months and 1 year.


Estimated Enrollment: 247
Study Start Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: one staged PCI
the patient randomized to this arms complete the myocardial revascularization in one stage PCI, the investigators treat all lesions.
Procedure: One-Stage group
Patients randomized to One-Stage group were completely revascularizated in one time PCI,
Active Comparator: multistaged PCI
the patients randomized to this arms in the first stage the investigators treat only the culprit lesion and in second stage the investigators treat the other vessels
Procedure: Multi-Staged group
patients randomized to Multi-Staged group were completely revascularizated in more time PCI, during the same hospitalization

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of NSTEMI
  • presenting with multivessel disease

Exclusion Criteria:

  • patients with cardiogenic shock at presentation
  • left main coronary disease (>50% diameter stenosis)
  • previous coronary artery bypass grafting (CABG) surgery
  • patients with Syntax Score >32
  • candidated to by-pass surgery
  • severe valvular heart disease
  • unsuccessful procedures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478984

Contacts
Contact: Gennaro Sardella, MD +390649979035 rino.sardella@uniroma1.it

Locations
Italy
Dept.of Cardiovascular Sciences,Policlinico Umberto I Recruiting
Rome, Italy, 00161
Contact: Luigi Lucisano, MD    +390649979044    luigilucisano@yahoo.it   
Contact: Massimo Mancone, MD, PhD    +390649979044    massimomancone@gmail.com   
Sponsors and Collaborators
Gennaro Sardella
  More Information

No publications provided

Responsible Party: Gennaro Sardella, Associate Professor in Cardiology, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01478984     History of Changes
Other Study ID Numbers: SMILE
Study First Received: November 11, 2011
Last Updated: November 21, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:
NSTEMI
PCI
onestage
multistaged

Additional relevant MeSH terms:
Angina, Unstable
Myocardial Infarction
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014