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OpenTrials
Completed

NCT Number: NCT00627809

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).

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Key information

Conditions

Acute Coronary Syndromes Acute Coronary Syndrome Acute Myocardial Infarction Cardiovascular Diseases Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology

Istanbul, 34290, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Streptokinase

Drug

intracoronary infusion, 250.000 Units

Other names: Streptase (Streptokinase)

Primary percutaneous coronary intervention

Procedure

balloon catheter, stent

Primary outcomes

  1. Left ventricular infarct size by SPECT

    Time frame: at long term (5-6 months)

  2. Left ventricular diastolic volume

    Time frame: at long term (5-6 months)

  3. Left ventricular systolic volume

    Time frame: at long term (5-6 months)

  4. Left ventricular ejection fraction

    Time frame: at long term (5-6 months)

Secondary outcomes

  1. 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)

  2. Reinfarction

    Time frame: from recruitment until the last follow-up at 5-6 months

  3. Major bleeding

    Time frame: from recruitment to discharge

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 3, 2008
Registry last updated
Jun 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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