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

Phase 4

Completed

• Conditions: Acute Coronary Syndromes; Acute Myocardial Infarction; Reperfusion Injury
• Interventions: Drug: Streptokinase; Procedure: primary percutaneous coronary intervention

• Registration Number: NCT00627809
• 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 limitation infarct size and improvement in left ventricular volumes and function in acute and late phases (6 months).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2008-01
• Study Completion: 2008-02
• Study First Submitted: 2008-02-22
• Study First Submitted QC: 2008-02-22
• Study First Posted: 2008-03-03
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-22
• Last Update Posted: 2009-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

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