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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00627809
First Posted: March 3, 2008
Last Update Posted: June 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Istanbul University
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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:


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) ]
  • Left ventricular diastolic volume [ Time Frame: at long term (5-6 months) ]
  • Left ventricular systolic volume [ Time Frame: at long term (5-6 months) ]
  • Left ventricular ejection fraction [ Time Frame: at long term (5-6 months) ]

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) ]
  • Reinfarction [ Time Frame: from recruitment until the last follow-up at 5-6 months ]
  • Major bleeding [ Time Frame: from recruitment to discharge ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: February 22, 2008
First Posted: March 3, 2008
Last Update Posted: June 23, 2009
Last Verified: June 2009

Keywords provided by Istanbul University:
coronary microcirculation
acut myocardial infarction
infarct size
streptokinase
reperfusion

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Reperfusion Injury
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Postoperative Complications
Streptokinase
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action