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

NCT00627809 | Completed Phase 4

• 1 other identifier: 2007-337
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Coronary Syndromes; Acute Myocardial Infarction; Reperfusion Injury

Keywords

coronary microcirculation; acut myocardial infarction; infarct size; streptokinase; reperfusion

Outcome Measures

Primary Outcomes (4)

• Left ventricular infarct size by SPECT

  at long term (5-6 months)

• Left ventricular diastolic volume

  at long term (5-6 months)

• Left ventricular systolic volume

  at long term (5-6 months)

• Left ventricular ejection fraction

  at long term (5-6 months)

Secondary Outcomes (3)

• 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.

  early phase (at discharge) and late phase (5-6 months)

• Reinfarction

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

• Major bleeding

  from recruitment to discharge

Study Arms (2)

1

EXPERIMENTAL

Following standard primary percutaneous coronary intervention for ST elevation acute myocardial infarction 250.000 U intracoronary Streptokinase will be given

Drug: Streptokinase; Procedure: primary percutaneous coronary intervention

2

ACTIVE COMPARATOR

Standard percutaneous coronary intervention for ST elevation myocardial infarction will be performed

Procedure: primary percutaneous coronary intervention

Interventions

Streptokinase DRUG

intracoronary infusion, 250.000 Units

Also known as: Streptase (Streptokinase)

1

primary percutaneous coronary intervention PROCEDURE

balloon catheter, stent

1; 2

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology

Istanbul, 34290, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 17476008 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Reperfusion Injury

Interventions

Streptokinase

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Murat Sezer, Assoc. Prof.

  Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology

  PRINCIPAL INVESTIGATOR

• Sabahattin Umman, Prof.

  Istanbul University,Istanbul Faculty of Medicine, Department of Cardiology

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 22, 2008
• First Posted: March 3, 2008
• Study Start: January 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: February 1, 2008
• Last Updated: June 23, 2009

Record last verified: 2009-06

Locations

TU (1)