Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction (NSTEMI) Patients: One Stage Versus Multistaged Percutaneous Coronary Intervention (PCI) (SMILE)
Impact of One Stage Compared With Multistaged PCI Complete Revascularization on Clinical Outcome in Multivessel NSTEMI Patients. Smile Trial
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Rome, Italia, 00161
- Rekruttering
- Dept.of Cardiovascular Sciences,Policlinico Umberto I
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Ta kontakt med:
- Luigi Lucisano, MD
- Telefonnummer: +390649979044
- E-post: luigilucisano@yahoo.it
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Ta kontakt med:
- Massimo Mancone, MD, PhD
- Telefonnummer: +390649979044
- E-post: massimomancone@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: one staged PCI
the patient randomized to this arms complete the myocardial revascularization in one stage PCI, the investigators treat all lesions.
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Patients randomized to One-Stage group were completely revascularizated in one time PCI,
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Aktiv komparator: 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
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patients randomized to Multi-Staged group were completely revascularizated in more time PCI, during the same hospitalization
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Major Adverese Cardiac and cerebral Events (MACCE)
Tidsramme: 12 months
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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.
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12 months
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Major Adverese Cardiac and cerebral Events (MACCE)
Tidsramme: 30 days
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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.
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30 days
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MACCE
Tidsramme: 6 months
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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.
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6 months
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Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SMILE
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