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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

This study has been completed.
Sponsor:
Information provided by:
Istanbul University
ClinicalTrials.gov Identifier:
NCT00302419
First received: March 13, 2006
Last updated: July 30, 2008
Last verified: July 2008

March 13, 2006
July 30, 2008
October 2004
February 2006   (final data collection date for primary outcome measure)
  • 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Index of microvascular resistance, [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Coronary flow reserve [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Left ventricular infarct size by SPECT at six months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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) with the assumption of that it is the ideal time to measure microvascular function. The study was designed to
  • • Index of microvascular resistance,
  • • Coronary flow reserve
  • Indices of microvascular perfusion:
  • • Coronary wedge pressure, systolic and mean
  • • Pressure-derived collateral flow index
  • • Deceleration time of the diastolic coronary flow (for LAD)
  • • Angiographic myocardial blush grades
  • • Corrected TIMI frame count
  • • ST segment resolution in ECG
Complete list of historical versions of study NCT00302419 on ClinicalTrials.gov Archive Site
  • Death [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Reinfarction [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Major bleeding [ Time Frame: during hospitalization ] [ Designated as safety issue: Yes ]
  • • Death (in hospital)
  • • Reinfarction
  • • Major bleeding
Not Provided
Not Provided
 
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
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Acute Myocardial Infarction
  • Drug: intracoronary infusion,
    streptokinase, 250,000 units
    Other Name: Streptase
  • Procedure: primary percutaneous coronary angioplasty
  • Experimental: 1
    Following standard primary percutaneous coronary intervention for ST elevation acute myocardial infarction 250.000 U intracoronary Streptokinase will be given
    Interventions:
    • Drug: intracoronary infusion,
    • Procedure: primary percutaneous coronary angioplasty
  • Active Comparator: 2
    Standard percutaneous coronary intervention for ST elevation myocardial infarction will be performed
    Intervention: Procedure: primary percutaneous coronary angioplasty

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
95
February 2008
February 2006   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT00302419
5737
Not Provided
Istanbul University Faculty of Medicine
Istanbul University
Not Provided
Study Director: Murat Sezer, M.D. Istanbul University, Istanbul School of Medicine
Principal Investigator: Sabahattin Umman, Prof. Istanbul University, Istanbul School of Medicine
Study Chair: Taner Goren, Prof. Istanbul University, Istanbul School of Medicine
Study Chair: Huseyin Oflaz, Assoc.Prof. Istanbul University, Istanbul School of Medicine
Study Chair: Irem Okcular, M.D. Istanbul University, Istanbul School of Medicine
Study Chair: Yılmaz Nisanci, Prof. Istanbul University, Istanbul School of Medicine
Study Chair: Berrin Umman, Prof. Istanbul University, Istanbul School of Medicine
Study Chair: Ahmet K Bilge, M.D. Istanbul University, Istanbul School of Medicine
Study Chair: Mehmet Meric, Prof. Istanbul University, Istanbul School of Medicine
Istanbul University
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP