Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction (RECOND)
8. februar 2016 opdateret af: John Pernow
Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction in Stockholm (RECOND)
- Trial objective: To test the hypothesis that remote per-postconditioning in connection with primary PCI will reduce myocardial infarct size patients with STEMI.
- Trial Design: Placebo controlled randomized study with parallel groups
- Primary Endpoint: Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance (CMR) day 4-7
- Efficacy Parameters: Myocardial infarct size expressed as a percentage to the myocardium at risk determined by CMR at 6 months.
- Global left ventricular function determined by left ventricular ejection fraction determined by CMR.
- Microvascular obstruction determined by CMR day 4-7. Quantified ECV (extracellular volume) in left ventricular as myocardium at risk day 4-7 and remodelling parameters day 180.
- Safety Parameters: Major adverse cardiovascular events.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
See above.
3 patients left to include.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
120
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Stockholm, Sverige
- Södersjukhuset
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Stockholm, Sverige
- Danderyds hospital
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Stockholm, Sverige, S-17176
- Karolinska University Hospital
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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:
- Patient planned for primary PCI.
- Chest pain indicating myocardial ischemia with a duration >30 minutes and < 6 hours prior to randomization.
- ST elevations >0.1 mV (>0.2 mV in V2-V3) in > two contiguous leads in V1-V6.
- Informed consent.
Exclusion Criteria:
- Previous myocardial infarction based on medical history or Q-wave on ECG in other area
- Left Bundle Branch Block on ECG.
- Previous CABG
- Cardiac arrest
- Any contraindication for CMR.
- Clinical symptoms of claudication
- Treatment with glibenclamide or cyclosporine on admission.
- Any condition that may interfere with the possibility for the patient to comply with or complete the study protocol.
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 |
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Aktiv komparator: Remote Ischemic per-postconditioning
Remote conditioning is induced by inflation of a blood pressure cuff around the left thigh to 200 mmHg or 20 mmHg above systolic blood pressure (if >180 mmHg) for 5 min followed by deflation for 5 min.
At least one of these conditioning cycles is performed before PCI is initiated.
If time allows, cycles of remote conditioning (5 min leg ischemia and 5 min reperfusion) are repeated until PCI is performed.
Following reperfusion, defined as first balloon inflation, four additional cycles of remote conditioning will be performed.
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Primary Percutanous Coronary Intervention is performed in both Groups.
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Sham-komparator: Sham
The sham procedures include application of the cuff around the thigh but it is not inflated. Otheriwize normal primary PCI. |
Primary Percutanous Coronary Intervention is performed in both Groups.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance
Tidsramme: 4-7 days following index event
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4-7 days following index event
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Myocardial infarct size expressed as a percentage to the myocardium at risk determined by Cardiac Magnetic Resonance
Tidsramme: 6 months following index event
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6 months following index event
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Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Global left ventricular function determined by left ventricular ejection fraction determined by CMR.
Tidsramme: 4-7 days and 6 months following index event
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4-7 days and 6 months following index event
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Microvascular obstruction determined by CMR
Tidsramme: 4-7 days following index event
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4-7 days following index event
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Quantified ECV (extracellular volume) in left ventricular as myocardium at risk
Tidsramme: 4-7 days following index event
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4-7 days following index event
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Myocardial infarct size by CMR expressed as a percentage to the myocardium at risk determined by Bari or modified Approach Score with coronary angiography.
Tidsramme: 5-7 days following index event
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5-7 days following index event
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: John Pernow, Professor, Karolinska Institutet
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. maj 2013
Primær færdiggørelse (Faktiske)
1. maj 2015
Studieafslutning (Faktiske)
1. november 2015
Datoer for studieregistrering
Først indsendt
20. december 2013
Først indsendt, der opfyldte QC-kriterier
20. december 2013
Først opslået (Skøn)
27. december 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
9. februar 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. februar 2016
Sidst verificeret
1. februar 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RECOND
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