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Effect of Complementary Intracoronary Streptokinase Administration Immediately After Primary Percutaneous Coronary Intervention on Microvascular Perfusion and Late Term Infarct Size in Patients With Acute Myocardial Infarction

30. juli 2008 opdateret af: Istanbul University
The investigators hypothesized that complementary intracoronary streptokinase administration to primary percutaneous intervention in patients with acute myocardial infarction may provide further improvement in myocardial perfusion by dissolving microvascular thrombus [in situ formed or embolized from proximal site (spontaneous or following PCI)] and fibrin.

Studieoversigt

Detaljeret beskrivelse

Mechanical reperfusion for acute myocardial infarction (AMI) targets optimal revascularization of the epicardial artery but also aims at improved myocardial salvage. The goal of reperfusion therapies has shifted to include reperfusion downstream at the level of capillary bed, and it might be more appropriate that the hypothesis now be termed "the time dependent open artery and open microvascular hypothesis." Failure to achieve myocardial reperfusion despite the presence of a patent coronary artery has been termed the "no-reflow" phenomenon and attributed to microvascular dysfunction. It has become apparent that clinical outcomes are not only associated with patency of the epicardial artery, but also with patency of the microcirculation. Persistent impairment of microcirculation is associated with poor clinical outcome. Complete reperfusion in AMI settings necessitates reopening of the all consecutive vascular compartments all the way through the coronary circulation. But, embolization following percutaneous coronary intervention (PCI) and in situ microthrombi generation at the microvascular level makes this goal difficult to achieve. For this reason, mechanical intervention to the epicardial coronary artery with or without using distal protection wouldn't be enough to achieve ideal reperfusion at the ultimate (microvascular) level. At this point, it has become more evident that we need to develop more competent and feasible reperfusion strategies which can help us to achieve reperfusion as complete as possible at all levels.

Hypothesis:

Complementary intracoronary streptokinase administration to primary PCI may provide further improvement in myocardial perfusion by dissolving microvascular thrombus [in situ formed or embolized from proximal site (spontaneous or following PCI)] and fibrin. Improvement in microvascular perfusion may translate into reduction in infarct size and improvement in left ventricular function at long term.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

95

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

      • Istanbul, Kalkun, 34290
        • Istanbul University, Istanbul School of Medicine, Department of Cardiology

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

20 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

  • Continuous chest pain that lasted > 30 minutes within the preceding 12 hours
  • ST-segment elevation of at least 1 mm in 2 contiguous leads on the 12 leads ECG
  • Infarct related artery (IRA) occlusion (TIMI grade 0) at the angiography
  • Angiographically detected culprit coronary artery lesion deemed suitable for PCI

Exclusion Criteria:

  • Contraindications to streptokinase, tirofiban, aspirin, clopidogrel, or heparin
  • Culprit lesion in saphenous vein graft
  • TIMI grade II-III flow in IRA
  • Additional epicardial stenosis in the IRA distal to stented segment (significant or insignificant)
  • Presence of left bundle branch block
  • History of prior MI
  • Mechanical ventilation or inotropic support

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Efter standard primær perkutan koronar intervention for ST-forhøjelse akut myokardieinfarkt 250.000 U intrakoronar streptokinase vil blive givet
streptokinase, 250,000 units
Andre navne:
  • Streptase
Aktiv komparator: 2
Standard perkutan koronar intervention for ST elevation myokardieinfarkt vil blive udført

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Primary end points defined as the indices of the microvascular perfusion which is going to be assessed on day 2 (48 hours after the primary PCI)and infarct size at 6 months.
Tidsramme: 6 months
6 months
Index of microvascular resistance,
Tidsramme: 48 hours
48 hours
Coronary flow reserve
Tidsramme: 48 hours
48 hours
Left ventricular infarct size by SPECT at six months.
Tidsramme: 6 months
6 months

Sekundære resultatmål

Resultatmål
Tidsramme
Død
Tidsramme: 1 år
1 år
Reinfarction
Tidsramme: 1 month
1 month
Major bleeding
Tidsramme: during hospitalization
during hospitalization

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Studieleder: Murat Sezer, M.D., Istanbul University, Istanbul School of Medicine
  • Ledende efterforsker: Sabahattin Umman, Prof., Istanbul University, Istanbul School of Medicine
  • Studiestol: Taner Goren, Prof., Istanbul University, Istanbul School of Medicine
  • Studiestol: Huseyin Oflaz, Assoc.Prof., Istanbul University, Istanbul School of Medicine
  • Studiestol: Irem Okcular, M.D., Istanbul University, Istanbul School of Medicine
  • Studiestol: Yılmaz Nisanci, Prof., Istanbul University, Istanbul School of Medicine
  • Studiestol: Berrin Umman, Prof., Istanbul University, Istanbul School of Medicine
  • Studiestol: Ahmet K Bilge, M.D., Istanbul University, Istanbul School of Medicine
  • Studiestol: Mehmet Meric, Prof., Istanbul University, Istanbul School of Medicine

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.

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. oktober 2004

Primær færdiggørelse (Faktiske)

1. februar 2006

Studieafslutning (Faktiske)

1. februar 2008

Datoer for studieregistrering

Først indsendt

13. marts 2006

Først indsendt, der opfyldte QC-kriterier

13. marts 2006

Først opslået (Skøn)

14. marts 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. august 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juli 2008

Sidst verificeret

1. juli 2008

Mere information

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 Akut myokardieinfarkt

Kliniske forsøg med intracoronary infusion,

3
Abonner