Clinical trial NCT00627809: Effect of Adjunctive Intracoronary Streptokinase on Late Term Left Ventricular Infarct Size and Volumes in Patients With Acute Myocardial Infarction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndromes
Acute Myocardial Infarction
Reperfusion Injury
Keywords: coronary microcirculation
acut myocardial infarction
infarct size
streptokinase
reperfusion
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2008-03-03
Enrollment: 53
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Left ventricular infarct size by SPECT
timeFrame: at long term (5-6 months)
measure: Left ventricular diastolic volume
timeFrame: at long term (5-6 months)
measure: Left ventricular systolic volume
timeFrame: at long term (5-6 months)
measure: Left ventricular ejection fraction
timeFrame: at long term (5-6 months)
Secondary outcomes:
measure: 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.
timeFrame: early phase (at discharge) and late phase (5-6 months)
measure: Reinfarction
timeFrame: from recruitment until the last follow-up at 5-6 months
measure: Major bleeding
timeFrame: from recruitment to discharge
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
Study officials:
affiliation: Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
name: Murat Sezer, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University,Istanbul Faculty of Medicine, Department of Cardiology
name: Sabahattin Umman, Prof.
role: STUDY_DIRECTOR
affiliation: Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
name: Arif O Cimen, M.D.
role: STUDY_CHAIR
affiliation: Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
name: Emre K Aslanger, M.D.
role: STUDY_CHAIR
affiliation: Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
name: Berrin Umman, Prof.
role: STUDY_CHAIR
affiliation: Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
name: Zehra Bugra, Prof.
role: STUDY_CHAIR
affiliation: Istanbul University, Istanbul Faculty of Medicine, Department of Nuclear Medicine
name: Isik Adalet, Prof.
role: STUDY_CHAIR
affiliation: Istanbul University, Istanbul Faculty of Medicine, Department of Nuclear Medicine
name: Cuneyt Turkmen, Assoc. Prof.
role: STUDY_CHAIR
References:
citation: 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.