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

NCT00627809 — Phase 4, Completed, 53 participants, Istanbul University

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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

Registry	NCT00627809
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	53 (Actual)
Sponsor	Istanbul University (Other)
Conditions	Acute Coronary Syndromes, Acute Myocardial Infarction, Reperfusion Injury
Interventions	Streptokinase, primary percutaneous coronary intervention (Drug, procedure)
Dates	start 2007-01-01, primary completion 2008-01-01, completion 2008-02-01, first posted 2008-03-03, last updated 2009-06-23
Locations	1 site in Turkey (Türkiye)

-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).

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+Arms and interventions

Arm	Type	Interventions	Description
1	Experimental	Drug: Streptokinase; Procedure: 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	Active comparator	Procedure: primary percutaneous coronary intervention	Standard percutaneous coronary intervention for ST elevation myocardial infarction will be performed

Streptokinase (Drug), also known as Streptase (Streptokinase): intracoronary infusion, 250.000 Units
primary percutaneous coronary intervention (Procedure): balloon catheter, stent

+Outcome measures

Primary outcomes

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 outcomes

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]

+Eligibility

Sex: All, ages: 20 Years to 75 Years

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

+Locations (1)

Facility	City	Country	Status
Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology	Istanbul	Turkey (Türkiye)

+Publications

Sezer M, Oflaz H, Goren T, Okcular I, Umman B, Nisanci Y, Bilge AK, Sanli Y, Meric M, Umman S. Intracoronary streptokinase after primary percutaneous coronary intervention. N Engl J Med. 2007 May 3;356(18):1823-34. doi: 10.1056/NEJMoa054374. PMID 17476008

+Investigators

Murat Sezer, Assoc. Prof., Principal investigator, Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
Sabahattin Umman, Prof., Study director, Istanbul University,Istanbul Faculty of Medicine, Department of Cardiology
Arif O Cimen, M.D., Study chair, Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
Emre K Aslanger, M.D., Study chair, Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
Berrin Umman, Prof., Study chair, Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
Zehra Bugra, Prof., Study chair, Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
Isik Adalet, Prof., Study chair, Istanbul University, Istanbul Faculty of Medicine, Department of Nuclear Medicine
Cuneyt Turkmen, Assoc. Prof., Study chair, Istanbul University, Istanbul Faculty of Medicine, Department of Nuclear Medicine