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

July 30, 2008 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months
Index of microvascular resistance,
Time Frame: 48 hours
48 hours
Coronary flow reserve
Time Frame: 48 hours
48 hours
Left ventricular infarct size by SPECT at six months.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Death
Time Frame: 1 year
1 year
Reinfarction
Time Frame: 1 month
1 month
Major bleeding
Time Frame: during hospitalization
during hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

March 13, 2006

First Submitted That Met QC Criteria

March 13, 2006

First Posted (Estimate)

March 14, 2006

Study Record Updates

Last Update Posted (Estimate)

August 1, 2008

Last Update Submitted That Met QC Criteria

July 30, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5737

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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