Effect of Adjunctive Intracoronary Streptokinase on Late Term Left Ventricular Infarct Size and Volumes in Patients With Acute Myocardial Infarction

Study Overview
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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 limitation infarct size and improvement in left ventricular volumes and function in acute and late phases (6 months).

Official Title
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Phase 4 Study of Application of Intracoronary Low Dose Streptokinase Complementary to Standard Percutaneous Coronary Intervention in Patients With ST Elevation Acute Myocardial Infarction: Effect of Adjunctive Intracoronary Streptokinase on Late Term Left Ventricular Infarct Size and Volumes in Patients With Acute Myocardial Infarction

Conditions
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Acute Coronary Syndromes, Acute Myocardial Infarction, Reperfusion Injury

Intervention / Treatment
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* Drug: Streptokinase
* Procedure: primary percutaneous coronary intervention


Participation Criteria
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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 ECG Infarct related artery (IRA) occlusion (TIMI grade 0) at the angiography 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Following standard primary percutaneous coronary intervention for ST elevation acute myocardial infarction 250.000 U intracoronary Streptokinase will be given | Drug: Streptokinase<br>* intracoronary infusion, 250.000 Units<br>* Other names: Streptase (Streptokinase);Procedure: primary percutaneous coronary intervention<br>* balloon catheter, stent<br>|
| Active Comparator: 2<br>Standard percutaneous coronary intervention for ST elevation myocardial infarction will be performed | Procedure: primary percutaneous coronary intervention<br>* balloon catheter, stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular infarct size by SPECT |  | at long term (5-6 months) | 
| Left ventricular diastolic volume |  | at long term (5-6 months) | 
| Left ventricular systolic volume |  | at long term (5-6 months) | 
| Left ventricular ejection fraction |  | at long term (5-6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temporal changes (from baseline to 5 months follow-up) in microvascular perfusion indices (index of microvascular resistance, coronary flow reserve) and in infarct size have been interrogated in only control group. |  | early phase (at discharge) and late phase (5-6 months) | 
| Reinfarction |  | from recruitment until the last follow-up at 5-6 months | 
| Major bleeding |  | from recruitment to discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary microcirculation, acut myocardial infarction, infarct size, streptokinase, reperfusion