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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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00302419
Enrollment
95
Registered
2006-03-14
Start date
2004-10-31
Completion date
2008-02-29
Last updated
2008-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardial infarction, primary angioplasty, streptokinase, microvasculature

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.

Interventions

DRUGintracoronary infusion,

streptokinase, 250,000 units

PROCEDUREprimary percutaneous coronary angioplasty

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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.6 months
Index of microvascular resistance,48 hours
Coronary flow reserve48 hours
Left ventricular infarct size by SPECT at six months.6 months

Secondary

MeasureTime frame
Reinfarction1 month
Major bleedingduring hospitalization
Death1 year

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026