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Target Temperature Management In Myocardial Infarction - A Pilot Study

24. maj 2013 opdateret af: Dr. Christoph Testori, Medical University of Vienna

The primary goal in the treatment of acute myocardial infarction is to reperfuse the ischemic myocardium to reduce infarct size. Animal data and human data suggest that whole-body cooling to temperatures below 35°C before revascularisation can additionally reduce infarct size and therefore improves outcome in these patients.

The purpose of the study is to determine the feasibility and safety of a combined cooling strategy started in the out-of-hospital arena for achieving pre-reperfusion hypothermia in patients with acute st-elevation myocardial infarction.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

19

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Østrig
      • Vienna, Østrig, 1090
        • Medical University of Vienna

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 til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age between 18 and 75 years
  • Immediately transfer to cath-lab is possible
  • Anterior or inferior ST-Elevation myocardial infarction
  • ST-Segment elevation of >0.2mV in 2 or more anatomically contiguous leads
  • Duration of symptoms <6 hours

Exclusion Criteria:

  • Participation in another study
  • Patients presenting with cardiac arrest
  • Tympanic temperature of <35.0°C prior enrolment
  • Thrombolysis therapy
  • Previous myocardial infarction in medical history
  • Previous percutaneous coronary intervention or coronary artery bypass graft
  • Severe heart failure (defined as a New York Heart Association (NYHA) score of III or IV), Killip class II through IV at presentation
  • Clinical signs of infection
  • End-stage kidney disease or hepatic failure
  • Recent stroke (within the last six month)
  • Conditions that may be exacerbated by hypothermia, such as haematological dyscrasias, oral anticoagulant treatment with international normalized radio >1.5, severe pulmonary disease
  • Pregnancy. Women of childbearing potential are excluded
  • Allergy to meperidine, buspirone, magnesium, or polyvinyl chloride
  • Use of a monoamine oxidase inhibitor such as selegiline in the previous 14 days

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Pre- and perinterventional hypothermia
Cooling will be initiated by the application of cooling pads in the out-of-hospital setting followed by an infusion of 1000-2000ml of cold saline. In the cath lab a endovascular cooling catheter will be placed into the inferior vena cava via a femoral vein to achieve a core temperature of <35°C prior to revascularization.
Enhed: EMCOOLS flex pad; Philips Innercool RTx
Surface cooling with EMCOOLS flex pads (out-of-hospital); Infusion of 1000ml to 2000ml of cold saline (out-of-hospital); central-venous cooling (Philips Innercool RTx)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of a combined cooling strategy for achieving a core temperature of <35.0°C at the time of reperfusion of the infarct related artery
Tidsramme: Time of reperfusion of the culprit lesion in st-elevation myocardial infarction (expected average 120 minutes)
Blood temperature will be recorded at the time of first wire-crossed lesion of the infarct related coronary stenosis
Time of reperfusion of the culprit lesion in st-elevation myocardial infarction (expected average 120 minutes)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety of a combined cooling strategy as an adjunctive therapy on primary percutaneous coronary intervention in acute st-elevation myocardial infarction
Tidsramme: within 45 days (+/- 15 days)
Incidence of major adverse cardiac events as defined as: death, heart failure, pulmonary edema, recurrent MI, malignant arrhythmias (i.e. ventricular fibrillation, sustained ventricular tachycardia) emergent stent revascularisation, any hospitalisation, major/minor bleeding (according to TIMI-bleeding score), infection (clinical relevant infection with the need of systemic antimicrobiotic therapy) within a period of 45±15 days
within 45 days (+/- 15 days)
Tolerability of a combined cooling strategy as an adjunctive therapy on primary percutaneous coronary intervention in acute st-elevation myocardial infarction
Tidsramme: during active cooling and rewarming (in average the first 4 hours)
Patients are monitored for incidence of shivering using a 4-point scale: 0, no shivering evident; 1, isolated facial or masticatory fasciculation; 2, peripheral shivering; 3, uncontrolled rigor during the cooling procedure (in average the first 4 hours)
during active cooling and rewarming (in average the first 4 hours)
Time to revascularisation (first medical contact to balloon time)
Tidsramme: Time of reperfusion (in average 120 minutes)
The time to reperfusion of the infarct related artery is crucial in acute ST-elevation myocardial infarction. To evaluate if the cooling procedure has a substantial influence on this time frame we measure the time from first medical contact to reperfusion.
Time of reperfusion (in average 120 minutes)

Samarbejdspartnere og efterforskere

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

Sponsor

Medical University of Vienna

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. september 2011

Primær færdiggørelse (Faktiske)

1. april 2013

Studieafslutning (Faktiske)

1. maj 2013

Datoer for studieregistrering

Først indsendt

17. maj 2013

Først indsendt, der opfyldte QC-kriterier

24. maj 2013

Først opslået (Skøn)

29. maj 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. maj 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. maj 2013

Sidst verificeret

1. maj 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STATIM-Pilot
  • MUW_492/2011

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 .

Kliniske forsøg med ST-elevation Myokardieinfarkt

Kliniske forsøg med EMCOOLS flex pad; Philips Innercool RTx

Søg i lignende forsøg

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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