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

Acute Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00302419
• Other study ID #: 5737
• Status: Completed
• Phase: Phase 4
• First received: March 13, 2006
• Last updated: July 30, 2008
• Start date: October 2004
• Est. completion date: February 2008

Study information

• Verified date: July 2008
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of HealthTurkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: February 2008
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• intracoronary infusion,
streptokinase, 250,000 units

Procedure:
• primary percutaneous coronary angioplasty

Locations

Country	Name	City	State
Turkey	Istanbul University, Istanbul School of Medicine, Department of Cardiology	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Index of microvascular resistance,		48 hours	No
Primary	Coronary flow reserve		48 hours	No
Primary	Left ventricular infarct size by SPECT at six months.		6 months	No
Secondary	Death		1 year	No
Secondary	Reinfarction		1 month	No
Secondary	Major bleeding		during hospitalization	Yes