Recruitment

Recruitment Status
Completed

Inclusion Criterias

onset of symptoms within 12 hours of hospital presentation
ST-segment elevation of more than 0.1 mV in two or more leads on the ECG
symptoms of myocardial ischemia lasting more than 30 minutes
...
onset of symptoms within 12 hours of hospital presentation
ST-segment elevation of more than 0.1 mV in two or more leads on the ECG
symptoms of myocardial ischemia lasting more than 30 minutes
patients 18-75 years old with myocardial infarction with ST-segment elevation

Exclusion Criterias

use of fibrinolytic drug within 12 hours of presentation
major bleeding diathesis
cardiogenic shock on presentation
...
use of fibrinolytic drug within 12 hours of presentation
major bleeding diathesis
cardiogenic shock on presentation
comorbidity with anticipated life expectancy of < 6 months
critical left main stem lesions
history of aspirin and clopidogrel intolerance
inability to obtain informed consent
severe calcfic disease precluding safe passage of the imaging catheter

Summary

Conditions
Acute ST Elevation Myocardial Infarction
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Description

Primary PCI has become the preferred therapy for ST-elevation acute myocardial infarction. The TAPAS trial data suggests that widespread adoption of manual thrombus aspiration may improve clinical outcomes for patients undergoing primary PCI. Little data exists on the degree to which thrombus is rem...

Primary PCI has become the preferred therapy for ST-elevation acute myocardial infarction. The TAPAS trial data suggests that widespread adoption of manual thrombus aspiration may improve clinical outcomes for patients undergoing primary PCI. Little data exists on the degree to which thrombus is removed during thrombectomy and how much thrombus remains with the potential for distal embolisation during stent deployment. The mechanism of lumen enlargement after thrombus aspiration is also unknown. Since angiography only provides an outline image of the vascular lumen, such questions cannot be adequately addressed by this modality alone. The aim of this study is to use IVUS to assess (1) culprit plaque morphology and thrombus burden in patients with ST-elevation myocardial infarction; (2) the efficacy of thrombus removal with an aspiration catheter during primary PCI. Hypotheses In this study we will assess 40 patients with STEMI. Primary PCI will be performed according to our hospital standard working protocol with thrombus aspiration and balloon dilatation of the culprit lesion if necessary prior to stent deployment. IVUS imaging will be undertaken prior to, and following, passage of the aspirations catheter to assess (1) initial and (2) residual thrombus volume. A third and final IVUS imaging run will be performed after stenting of the culprit lesion. IVUS analysis will be performed off-line to assess the lumen enlargement and volume of residual thrombus at each stage. All studies will be undertaken with the approval of the local Clinical Research Ethics. Aspirated material will be collected and analyzed. Clinical markers such as Troponin release and left ventricular function will be assessed.

Inclusion Criterias

onset of symptoms within 12 hours of hospital presentation
ST-segment elevation of more than 0.1 mV in two or more leads on the ECG
symptoms of myocardial ischemia lasting more than 30 minutes
...
onset of symptoms within 12 hours of hospital presentation
ST-segment elevation of more than 0.1 mV in two or more leads on the ECG
symptoms of myocardial ischemia lasting more than 30 minutes
patients 18-75 years old with myocardial infarction with ST-segment elevation

Exclusion Criterias

use of fibrinolytic drug within 12 hours of presentation
major bleeding diathesis
cardiogenic shock on presentation
...
use of fibrinolytic drug within 12 hours of presentation
major bleeding diathesis
cardiogenic shock on presentation
comorbidity with anticipated life expectancy of < 6 months
critical left main stem lesions
history of aspirin and clopidogrel intolerance
inability to obtain informed consent
severe calcfic disease precluding safe passage of the imaging catheter

Locations

Newcastle
Newcastle

Tracking Information

NCT #
NCT01878487
Collaborators
Not Provided
Investigators
Not Provided