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

Phase 4

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Drug: intracoronary infusion,; Procedure: primary percutaneous coronary angioplasty

• Registration Number: NCT00302419
• Lead Sponsor: Istanbul University

Brief Summary

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

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 Timeline

• Study Start: 2004-10
• Primary Completion: 2006-02
• Study First Submitted: 2006-03-13
• Study First Submitted QC: 2006-03-13
• Study First Posted: 2006-03-14
• Study Completion: 2008-02
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-30
• Last Update Posted: 2008-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	intracoronary infusion,	Following standard primary percutaneous coronary intervention for ST elevation acute myocardial infarction 250.000 U intracoronary Streptokinase will be given
1	primary percutaneous coronary angioplasty	Following standard primary percutaneous coronary intervention for ST elevation acute myocardial infarction 250.000 U intracoronary Streptokinase will be given
2	primary percutaneous coronary angioplasty	Standard percutaneous coronary intervention for ST elevation myocardial infarction will be performed

Primary Outcome Measures

Name	Time	Method
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.	6 months
Index of microvascular resistance,	48 hours
Coronary flow reserve	48 hours
Left ventricular infarct size by SPECT at six months.	6 months

Secondary Outcome Measures

Name	Time	Method
Death	1 year
Reinfarction	1 month
Major bleeding	during hospitalization

Trial Locations

Locations (1)

Istanbul University, Istanbul School of Medicine, Department of Cardiology; 🇹🇷 Istanbul, Turkey