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

June 22, 2009 updated by: Istanbul University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Left ventricular infarct size by SPECT
Time Frame: at long term (5-6 months)
at long term (5-6 months)
Left ventricular diastolic volume
Time Frame: at long term (5-6 months)
at long term (5-6 months)
Left ventricular systolic volume
Time Frame: at long term (5-6 months)
at long term (5-6 months)
Left ventricular ejection fraction
Time Frame: at long term (5-6 months)
at long term (5-6 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
early phase (at discharge) and late phase (5-6 months)
Reinfarction
Time Frame: from recruitment until the last follow-up at 5-6 months
from recruitment until the last follow-up at 5-6 months
Major bleeding
Time Frame: from recruitment to discharge
from recruitment to discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

February 22, 2008

First Submitted That Met QC Criteria

February 22, 2008

First Posted (Estimate)

March 3, 2008

Study Record Updates

Last Update Posted (Estimate)

June 23, 2009

Last Update Submitted That Met QC Criteria

June 22, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-337

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Reperfusion Injury

Clinical Trials on Streptokinase

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe