- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00302419
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
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
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
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Istanbul, Kalkun, 34290
- Istanbul University, Istanbul School of Medicine, Department of Cardiology
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
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:
|
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
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6 months
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Index of microvascular resistance,
Tidsramme: 48 hours
|
48 hours
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Coronary flow reserve
Tidsramme: 48 hours
|
48 hours
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Left ventricular infarct size by SPECT at six months.
Tidsramme: 6 months
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6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Død
Tidsramme: 1 år
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1 år
|
Reinfarction
Tidsramme: 1 month
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1 month
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Major bleeding
Tidsramme: during hospitalization
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during hospitalization
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Samarbejdspartnere og efterforskere
Sponsor
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
Generelle publikationer
- Sezer M, Cimen A, Aslanger E, Elitok A, Umman B, Bugra Z, Yormaz E, Turkmen C, Adalet IS, Nisanci Y, Umman S. Effect of intracoronary streptokinase administered immediately after primary percutaneous coronary intervention on long-term left ventricular infarct size, volumes, and function. J Am Coll Cardiol. 2009 Sep 15;54(12):1065-71. doi: 10.1016/j.jacc.2009.04.083.
- Sezer M, Oflaz H, Goren T, Okcular I, Umman B, Nisanci Y, Bilge AK, Sanli Y, Meric M, Umman S. Intracoronary streptokinase after primary percutaneous coronary intervention. N Engl J Med. 2007 May 3;356(18):1823-34. doi: 10.1056/NEJMoa054374.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 5737
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