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

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627809
• Other study ID #: 2007-337
• Status: Completed
• Phase: Phase 4
• First received: February 22, 2008
• Last updated: June 22, 2009
• Start date: January 2007
• Est. completion date: February 2008

Study information

• Verified date: June 2009
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• 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 limitation infarct size and improvement in left ventricular volumes and function in acute and late phases (6 months).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 2008
• Est. primary completion date: January 2008
• 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 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

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 Coronary Syndrome
• Acute Coronary Syndromes
• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction
• Reperfusion Injury

Intervention

Drug:
• Streptokinase
intracoronary infusion, 250.000 Units

Procedure:
• primary percutaneous coronary intervention
balloon catheter, stent

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Sezer M, Oflaz H, Gören T, Okçular I, Umman B, Nisanci Y, Bilge AK, Sanli Y, Meriç M, Umman S. Intracoronary streptokinase after primary percutaneous coronary intervention. N Engl J Med. 2007 May 3;356(18):1823-34. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular infarct size by SPECT		at long term (5-6 months)	No
Primary	Left ventricular diastolic volume		at long term (5-6 months)	No
Primary	Left ventricular systolic volume		at long term (5-6 months)	No
Primary	Left ventricular ejection fraction		at long term (5-6 months)	No
Secondary	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)	No
Secondary	Reinfarction		from recruitment until the last follow-up at 5-6 months	Yes
Secondary	Major bleeding		from recruitment to discharge	Yes