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

Sponsor:	Istanbul University
Information provided by:	Istanbul University
ClinicalTrials.gov Identifier:	NCT00627809

Purpose

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).

Condition	Intervention	Phase
Acute Coronary Syndromes Acute Myocardial Infarction Reperfusion Injury	Drug: Streptokinase Procedure: primary percutaneous coronary intervention	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

Drug Information available for: Streptokinase

U.S. FDA Resources

Further study details as provided by Istanbul University:

Primary Outcome Measures:

Left ventricular infarct size by SPECT [ Time Frame: at long term (5-6 months) ] [ Designated as safety issue: No ]
Left ventricular diastolic volume [ Time Frame: at long term (5-6 months) ] [ Designated as safety issue: No ]
Left ventricular systolic volume [ Time Frame: at long term (5-6 months) ] [ Designated as safety issue: No ]
Left ventricular ejection fraction [ Time Frame: at long term (5-6 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: early phase (at discharge) and late phase (5-6 months) ] [ Designated as safety issue: No ]
Reinfarction [ Time Frame: from recruitment until the last follow-up at 5-6 months ] [ Designated as safety issue: Yes ]
Major bleeding [ Time Frame: from recruitment to discharge ] [ Designated as safety issue: Yes ]

Enrollment:	53
Study Start Date:	January 2007
Study Completion Date:	February 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Following standard primary percutaneous coronary intervention for ST elevation acute myocardial infarction 250.000 U intracoronary Streptokinase will be given	Drug: Streptokinase intracoronary infusion, 250.000 Units Other Name: Streptase (Streptokinase) Procedure: primary percutaneous coronary intervention balloon catheter, stent
Active Comparator: 2 Standard percutaneous coronary intervention for ST elevation myocardial infarction will be performed	Procedure: primary percutaneous coronary intervention balloon catheter, stent

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627809

Locations

Turkey
Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
Istanbul, Turkey, 34290

Sponsors and Collaborators

Istanbul University

Investigators

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

More Information

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.

Responsible Party:	Istanbul University, Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
ClinicalTrials.gov Identifier:	NCT00627809 History of Changes
Other Study ID Numbers:	2007-337
Study First Received:	February 22, 2008
Last Updated:	June 22, 2009
Health Authority:	Turkey: Ministry of Health

Keywords provided by Istanbul University:

coronary microcirculation
acut myocardial infarction
infarct size
streptokinase
reperfusion

Additional relevant MeSH terms:

Infarction
Myocardial Infarction
Reperfusion Injury
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Postoperative Complications

Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Streptokinase
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on February 09, 2012