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Postconditioning in ST-elevation Myocardial Infarction (POSTEMI)

26. september 2016 opdateret af: Jan Eritsland, Oslo University Hospital

Postconditioning in ST-elevation Myocardial Infarction Treated With Primary PCI

Study objectives: To assess the effects of postconditioning on infarct size in patients with ST-elevation infarction referred to PCI.

Study design: Prospective, randomized, open-label study with blinded endpoint evaluation. Included patients will be randomly allocated to postconditioning or control. Patients with symptoms of acute myocardial infarction of less than 6 hours duration fulfilling ECG criteria for primary PCI are eligible. PCI follow established routines. In postconditioning patients, additional, short (1 min), intermittent balloon occlusions will be applied after initial opening of infarct related artery. After this intervention, PCI proceeds routinely with stent implantation. In the control group, stent implantation after initial opening proceeds as usual. Primary endpoint is final infarct size, determined by MRI after 4 months. 260 patients will be included. Follow-up is 1 year. Inclusion period: 18 - 24 months.

Clinical implications: Reperfusion therapy, administered as early as possible after start of symptoms, has improved the prognosis in acute ST-elevation myocardial infarction. Still, however, many patients suffer large infarctions, subsequently with an increased risk of heart failure, arrhythmias, and death. In pilot studies, mechanical postconditioning has been shown to reduce infarct size and thus potentially improve prognosis. However, the effect of postconditioning must be confirmed in larger clinical trials before implemented in routine treatment.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

272

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Norge
      • Oslo, Norge, N-0407
        • Dept. of Cardiology, Oslo Univ. Hosp. Ulleval

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:

  • acute symptoms consistent with an acute myocardial infarction of less than 6 hours duration
  • an occluded infarct related artery must be demonstrated (TIMI-flow 0-1)

Exclusion Criteria:

  • Prior myocardial infarction
  • Demonstration of collaterals to the infarcted area
  • TIMI-flow >1 before intervention or TIMI-flow <2 after initial balloon inflation
  • Demonstration of a distal occlusion
  • Patients given thrombolytic treatment
  • Patients in cardiogenic shock
  • Any contraindication to MRI (magnetic resonance imaging)
  • Unwillingness to participate

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Postconditioning
Active arm:Postconditioning protocol before routine PCI/stenting of an occluded coronary artery
Procedure: Postconditioning
After opening of IRA and establishment of TIMI-flow grade 2 or 3, the control group continues the procedure with stenting. In the postconditioning group 4 additional balloon inflations separated by 1 minute reperfusion are given, starting after 1 minute of reperfusion.
Andet: Control
Control arm: Routine PCI/stenting of an occluded coronary artery without postconditioning
Procedure: Control intervention
After opening of IRA and establishment of TIMI-flow grade 2 or 3, the control group continues the procedure with stenting.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Infarct size, assessed by MRI
Tidsramme: 4 months
4 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Myocardial blushing grade
Tidsramme: assessed at the end of PCI procedure
assessed at the end of PCI procedure
ST-resolution in ECG
Tidsramme: Assessed after 1 hour
Assessed after 1 hour
Troponin-T and CK-MB
Tidsramme: peak release values
peak release values
Echocardiographic evaluation of left ventricular function including speckle-tracking measurement.
Tidsramme: assessed at baseline, 4 months and1 year
Assesment of LV function. Comparison with CMR in the whole study population and between treatment groups.
assessed at baseline, 4 months and1 year
Incidence of treated arrhythmias and heart failure during initial hospitalization Incidence of death, non-fatal myocardial infarction, unstable angina, heart failure, and cerebrovascular disease
Tidsramme: 1-year follow up.
1-year follow up.
Myocardial salvage
Tidsramme: Baseline to 4 months
Myocardial salvage defined as (area at risk-final infarct size)/area at risk. Area at risk measured by CMR at baseline and final infarct size by CMR at 4 months.
Baseline to 4 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Oslo University Hospital

Efterforskere

  • Studiestol: Jan Eritsland, MD, PhD, Oslo Univ.Hosp. Ulleval

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. juni 2009

Primær færdiggørelse (Faktiske)

1. august 2012

Studieafslutning (Faktiske)

1. august 2013

Datoer for studieregistrering

Først indsendt

16. juni 2009

Først indsendt, der opfyldte QC-kriterier

16. juni 2009

Først opslået (Skøn)

17. juni 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. september 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. september 2016

Sidst verificeret

1. september 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Po 1506

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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