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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2008-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Myocardial Infarction

Keywords

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Acute myocardial infarction primary angioplasty streptokinase microvasculature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1

Following standard primary percutaneous coronary intervention for ST elevation acute myocardial infarction 250.000 U intracoronary Streptokinase will be given

Group Type EXPERIMENTAL

intracoronary infusion,

Intervention Type DRUG

streptokinase, 250,000 units

primary percutaneous coronary angioplasty

Intervention Type PROCEDURE

2

Standard percutaneous coronary intervention for ST elevation myocardial infarction will be performed

Group Type ACTIVE_COMPARATOR

primary percutaneous coronary angioplasty

Intervention Type PROCEDURE

Interventions

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intracoronary infusion,

streptokinase, 250,000 units

Intervention Type DRUG

primary percutaneous coronary angioplasty

Intervention Type PROCEDURE

Other Intervention Names

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Streptase

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Istanbul University Faculty of Medicine