search
Back to results

Effect of Complementary Intracoronary Streptokinase Administration Immediately After Primary Percutaneous Coronary Intervention on Microvascular Perfusion and Late Term Infarct Size in Patients With Acute Myocardial Infarction

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
intracoronary infusion,
primary percutaneous coronary angioplasty
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Acute myocardial infarction, primary angioplasty, streptokinase, microvasculature

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 12 leads ECG Infarct related artery (IRA) occlusion (TIMI grade 0) at the angiography Angiographically detected culprit coronary artery lesion deemed suitable for PCI 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 Mechanical ventilation or inotropic support

Sites / Locations

  • Istanbul University, Istanbul School of Medicine, Department of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Primary end points defined as the indices of the microvascular perfusion which is going to be assessed on day 2 (48 hours after the primary PCI)and infarct size at 6 months.
Index of microvascular resistance,
Coronary flow reserve
Left ventricular infarct size by SPECT at six months.

Secondary Outcome Measures

Death
Reinfarction
Major bleeding

Full Information

First Posted
March 13, 2006
Last Updated
July 30, 2008
Sponsor
Istanbul University
search

1. Study Identification

Unique Protocol Identification Number
NCT00302419
Brief Title
Effect of Complementary Intracoronary Streptokinase Administration Immediately After Primary Percutaneous Coronary Intervention on Microvascular Perfusion and Late Term Infarct Size in Patients With Acute Myocardial Infarction
Official Title
Effect of Complementary Intracoronary Streptokinase Administration Immediately After Primary Percutaneous Coronary Intervention on Microvascular Perfusion and Late Term Infarct Size in Patients With Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Istanbul University

4. Oversight

5. Study Description

Brief Summary
The investigators hypothesized that complementary intracoronary streptokinase administration to primary percutaneous intervention in patients with acute myocardial infarction may provide further improvement in myocardial perfusion by dissolving microvascular thrombus [in situ formed or embolized from proximal site (spontaneous or following PCI)] and fibrin.
Detailed Description
Mechanical reperfusion for acute myocardial infarction (AMI) targets optimal revascularization of the epicardial artery but also aims at improved myocardial salvage. The goal of reperfusion therapies has shifted to include reperfusion downstream at the level of capillary bed, and it might be more appropriate that the hypothesis now be termed "the time dependent open artery and open microvascular hypothesis." Failure to achieve myocardial reperfusion despite the presence of a patent coronary artery has been termed the "no-reflow" phenomenon and attributed to microvascular dysfunction. It has become apparent that clinical outcomes are not only associated with patency of the epicardial artery, but also with patency of the microcirculation. Persistent impairment of microcirculation is associated with poor clinical outcome. Complete reperfusion in AMI settings necessitates reopening of the all consecutive vascular compartments all the way through the coronary circulation. But, embolization following percutaneous coronary intervention (PCI) and in situ microthrombi generation at the microvascular level makes this goal difficult to achieve. For this reason, mechanical intervention to the epicardial coronary artery with or without using distal protection wouldn't be enough to achieve ideal reperfusion at the ultimate (microvascular) level. At this point, it has become more evident that we need to develop more competent and feasible reperfusion strategies which can help us to achieve reperfusion as complete as possible at all levels. Hypothesis: Complementary intracoronary streptokinase administration to primary PCI may provide further improvement in myocardial perfusion by dissolving microvascular thrombus [in situ formed or embolized from proximal site (spontaneous or following PCI)] and fibrin. Improvement in microvascular perfusion may translate into reduction in infarct size and improvement in left ventricular function at long term.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Acute myocardial infarction, primary angioplasty, streptokinase, microvasculature

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Following standard primary percutaneous coronary intervention for ST elevation acute myocardial infarction 250.000 U intracoronary Streptokinase will be given
Arm Title
2
Arm Type
Active Comparator
Arm Description
Standard percutaneous coronary intervention for ST elevation myocardial infarction will be performed
Intervention Type
Drug
Intervention Name(s)
intracoronary infusion,
Other Intervention Name(s)
Streptase
Intervention Description
streptokinase, 250,000 units
Intervention Type
Procedure
Intervention Name(s)
primary percutaneous coronary angioplasty
Primary Outcome Measure Information:
Title
Primary end points defined as the indices of the microvascular perfusion which is going to be assessed on day 2 (48 hours after the primary PCI)and infarct size at 6 months.
Time Frame
6 months
Title
Index of microvascular resistance,
Time Frame
48 hours
Title
Coronary flow reserve
Time Frame
48 hours
Title
Left ventricular infarct size by SPECT at six months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Death
Time Frame
1 year
Title
Reinfarction
Time Frame
1 month
Title
Major bleeding
Time Frame
during hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 12 leads ECG Infarct related artery (IRA) occlusion (TIMI grade 0) at the angiography Angiographically detected culprit coronary artery lesion deemed suitable for PCI 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 Mechanical ventilation or inotropic support
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murat Sezer, M.D.
Organizational Affiliation
Istanbul University, Istanbul School of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sabahattin Umman, Prof.
Organizational Affiliation
Istanbul University, Istanbul School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Taner Goren, Prof.
Organizational Affiliation
Istanbul University, Istanbul School of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Huseyin Oflaz, Assoc.Prof.
Organizational Affiliation
Istanbul University, Istanbul School of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Irem Okcular, M.D.
Organizational Affiliation
Istanbul University, Istanbul School of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yılmaz Nisanci, Prof.
Organizational Affiliation
Istanbul University, Istanbul School of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Berrin Umman, Prof.
Organizational Affiliation
Istanbul University, Istanbul School of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmet K Bilge, M.D.
Organizational Affiliation
Istanbul University, Istanbul School of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mehmet Meric, Prof.
Organizational Affiliation
Istanbul University, Istanbul School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul University, Istanbul School of Medicine, Department of Cardiology
City
Istanbul
ZIP/Postal Code
34290
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
19744615
Citation
Sezer M, Cimen A, Aslanger E, Elitok A, Umman B, Bugra Z, Yormaz E, Turkmen C, Adalet IS, Nisanci Y, Umman S. Effect of intracoronary streptokinase administered immediately after primary percutaneous coronary intervention on long-term left ventricular infarct size, volumes, and function. J Am Coll Cardiol. 2009 Sep 15;54(12):1065-71. doi: 10.1016/j.jacc.2009.04.083.
Results Reference
derived
PubMed Identifier
17476008
Citation
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.
Results Reference
derived

Learn more about this trial

Effect of Complementary Intracoronary Streptokinase Administration Immediately After Primary Percutaneous Coronary Intervention on Microvascular Perfusion and Late Term Infarct Size in Patients With Acute Myocardial Infarction

We'll reach out to this number within 24 hrs