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

Primary Purpose

Acute Coronary Syndromes, Acute Myocardial Infarction, Reperfusion Injury

Status

Completed

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

Streptokinase

primary percutaneous coronary intervention

About this trial

This is an interventional treatment trial for Acute Coronary Syndromes focused on measuring coronary microcirculation, acut myocardial infarction, infarct size, streptokinase, reperfusion

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 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

Sites / Locations

Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Left ventricular infarct size by SPECT

Left ventricular diastolic volume

Left ventricular systolic volume

Left ventricular ejection fraction

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.

Reinfarction

Major bleeding

Full Information

NCT ID

NCT00627809

First Posted

February 22, 2008

Last Updated

June 22, 2009

Sponsor

Istanbul University

1. Study Identification

Unique Protocol Identification Number

NCT00627809

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Istanbul University

4. Oversight

Data Monitoring Committee

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 limitation infarct size and improvement in left ventricular volumes and function in acute and late phases (6 months).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndromes, Acute Myocardial Infarction, Reperfusion Injury

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Streptokinase

Other Intervention Name(s)

Streptase (Streptokinase)

Intervention Description

intracoronary infusion, 250.000 Units

Intervention Type

Procedure

Intervention Name(s)

primary percutaneous coronary intervention

Intervention Description

balloon catheter, stent

Primary Outcome Measure Information:

Title

Left ventricular infarct size by SPECT

Time Frame

at long term (5-6 months)

Title

Left ventricular diastolic volume

Time Frame

at long term (5-6 months)

Title

Left ventricular systolic volume

Time Frame

at long term (5-6 months)

Title

Left ventricular ejection fraction

Time Frame

at long term (5-6 months)

Secondary Outcome Measure Information:

Title

Time Frame

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

Title

Reinfarction

Time Frame

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

Title

Major bleeding

Time Frame

from recruitment to discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 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

Overall Study Officials: