Multivessel Stenting Versus Staged Revascularization With Zotarolimus-eluting Stent for STEMI (ZES for STEMI)
30. januar 2013 opdateret af: Dr. Vladimir Ganyukov, Russian Academy of Medical Sciences
Multivessel Stenting and Staged Revascularization for ST-elevation Myocardial Infarction Patients With Resolute Integrity Stents
The purpose of this study is to determine outcomes (death, myocardial infarction, target vessel revascularization (TVR), non-target vessel revascularization (non-TVR), stent-thrombosis) of 120 consecutive patients with ST elevation myocardial infarction and multivessel coronary artery disease undergoing multivessel stenting or staged percutaneous coronary intervention with Zotarolimus-eluting stents
Studieoversigt
Status
Ukendt
Intervention / Behandling
Detaljeret beskrivelse
Multivessel coronary artery disease has been reported to occur in 40 to 67% of ST elevation myocardial infarction (STEMI) patients.
Multivessel coronary artery disease (MVCD) patients, who have experienced STEMI, are at a high risk of major cardiovascular events (MACE) within one year after primary PCI.
While MACE incidence in patients with one-vessel coronary artery disease is about 14.5%, patients with two- and three-vessel lesions experience MACE in 19.5% and 23.6% of cases, respectively.
The risk of death in a 5-year follow-up increases two-fold in MVCD patients.
This risk can be partly explained by slower recovery of left ventricular function and progression of left ventricular pathological remodeling process after MI.
In addition, the mere presence of MVCD has been shown to be associated with MACE development in the long-term period.
There are several treatment strategies for ST-elevation myocardial infarction (STEMI) patients with MVCD: infarct related artery (IRA)-only percutaneous coronary intervention (PCI), multivessel stenting in the primary PCI setting and staged revascularisation.
The current guidelines for STEMI revascularisation give no definite instructions on the need for concurrent non-IRA intervention in patients with stable haemodynamics.
At present, there are not clinical trials testing the current Zotarolimus-eluting stents (ZES) in STEMI patients with MVCD undergoing primary PCI for different strategies of revascularization.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
120
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Kemerovo Region
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Kemerovo, Kemerovo Region, Den Russiske Føderation, 650002
- Rekruttering
- State Research Institute for Complex Issues of Cardiovascular Diseases
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Kontakt:
- Vladimir Ganyukov, MD, PhD
- Telefonnummer: +79131273905
- E-mail: ganyukov@mail.ru
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Kontakt:
- Roman Tarasov, MD, PhD
- Telefonnummer: +79235260446
- E-mail: roman.tarasov@mail.ru
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Ledende efterforsker:
- Vladimir Ganyukov, MD, PhD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Subject must be at least 18 years of age.
- Subject is able to verbally confirm understandings of risks, benefits of treatment of either multivessel stenting or staged PCI using the zotarolimus-eluting stent (Resolute Integrity™ Stent, Medtronic) and he or she or his or her legally authorized representative provides written informed consent prior to any study related procedure.
- Subject must have significant stenoses (≥ 70%) of two or more than two of coronary arteries and requiring primary PCI for acute ST elevation myocardial infarction (STEMI) within 12hrs
- Target lesion(s) must be located in a native coronary artery with visually estimated diameter of less than 2.5 mm and more than 4.0 mm.
- Target lesion(s) must be amenable for percutaneous coronary intervention
Exclusion Criteria:
- The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin Aspirin Both Clopidogrel and Ticlopidine, Zotarolimus
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 6 months post enrollment.
- Non-cardiac comorbid conditions are present with life expectancy over 1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- Acute heart failure Killip III-IV
- ≥ 50% left main stenosis
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Multivessel stenting
This group comprises the patients who undergo a one-time primary percutaneous coronary intervention (PCI) of the culprit and nonculprit lesions
|
Multivessel stenting or Staged PCI with Zotarolimus-eluting coronary stent in STEMI patients
Andre navne:
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Aktiv komparator: Staged revascularization
This group comprises the patients who undergo PCI of only the culprit lesion and staged nonculprit PCI at a later date (3-15 days)
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Multivessel stenting or Staged PCI with Zotarolimus-eluting coronary stent in STEMI patients
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
All death including cardiac and non cardiac death
Tidsramme: 30 days, 6 months and 12 montrhs
|
30 days, 6 months and 12 montrhs
|
|
Recurrent MI
Tidsramme: 30 days, 6 months and 12 months
|
30 days, 6 months and 12 months
|
|
Any revascularizations (TLR or TVR)
Tidsramme: 30 days, 6 months and 12 months
|
30 days, 6 months and 12 months
|
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Composite rate of all death, any MI and any repeat revascularization
Tidsramme: 30 days, 6 months and 12 months
|
30 days, 6 months and 12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
stent thrombosis
Tidsramme: 30 days. 6 months and 12 months
|
The incidence of stent thrombosis was assessed throughout the follow-up period, according to the conventional ARC (Academic Research Consortium) classification.
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30 days. 6 months and 12 months
|
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Non-TVR
Tidsramme: 30 days, 6 months and 12 months
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Any repeat revascularization of non target vessels
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30 days, 6 months and 12 months
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Composite rate of all death, any MI and any repeat revascularization
Tidsramme: 30 days, 6 months and 12 months
|
30 days, 6 months and 12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2011
Primær færdiggørelse (Forventet)
1. december 2013
Studieafslutning (Forventet)
1. december 2014
Datoer for studieregistrering
Først indsendt
29. januar 2013
Først indsendt, der opfyldte QC-kriterier
30. januar 2013
Først opslået (Skøn)
1. februar 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
1. februar 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. januar 2013
Sidst verificeret
1. januar 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Resolute Integrity for STEMI
- ZES for STEMI (Andet bevillings-/finansieringsnummer: Medtronic)
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