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
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
Drug: intracoronary infusion,
Procedure: primary percutaneous coronary angioplasty
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Istanbul University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 95
Study Start Date: October 2004
Study Completion Date: February 2008
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Following standard primary percutaneous coronary intervention for ST elevation acute myocardial infarction 250.000 U intracoronary Streptokinase will be given
Drug: intracoronary infusion,
streptokinase, 250,000 units
Other Name: Streptase
Procedure: primary percutaneous coronary angioplasty
Active Comparator: 2
Standard percutaneous coronary intervention for ST elevation myocardial infarction will be performed
Procedure: primary percutaneous coronary angioplasty

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00302419

Locations
Turkey
Istanbul University, Istanbul School of Medicine, Department of Cardiology
Istanbul, Turkey, 34290
Sponsors and Collaborators
Istanbul University
Investigators
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
  More Information

No publications provided by Istanbul University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Istanbul University Faculty of Medicine
ClinicalTrials.gov Identifier: NCT00302419     History of Changes
Other Study ID Numbers: 5737
Study First Received: March 13, 2006
Last Updated: July 30, 2008
Health Authority: Turkey: Ministry of Health
Turkey: Ethics Committee

Keywords provided by Istanbul University:
Acute myocardial infarction
primary angioplasty
streptokinase
microvasculature

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Streptokinase
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on September 18, 2014