Aspiration Device in Myocardial Infarction Trial

Not Applicable

• Conditions: Angioplasty

• Registration Number: NCT00370578
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

Early promising data are published focusing on the role of manual thrombus aspiration devices in patients with ST segment elevation (STEMI).

The aim of our single center randomized study is to evaluate the early and late effect of thrombus aspiration device (AD) after every stage during Primary PCI in the set-up of STEMI population.

Our hypothysis is that preforming thrombus aspiration after every stage of primary PCI may give early and late advantages compared to the standard primary PCI technique.

Detailed Description

ADMIT-Randomized Single Center Study with two arms:

Standard PCI versus Primary PCI, using thrombus aspiration device after ever step of the procedure.

Issues to be examined are:

1. Immediate angiographic differences between the study arms. By evaluation of: TIMI FLOW GRADE,TIMI FRAME COUNT,MYOCARDIAL BLUSH GRADE. No reflow phenomenae,

2. Infarc size evaluated by serum markers and non invasive parameters

3. In hospital major adverse cardiac events

4. Major adverse cardiac events during 30\& 180 days of follow up

Study Timeline

• Status Verified: 2006-08
• Study First Submitted: 2006-08-09
• Study First Submitted QC: 2006-08-30
• Study First Posted: 2006-08-31
• Study Start: 2006-09
• Last Update Submitted: 2007-08-27
• Last Update Posted: 2007-08-28
• Study Completion: 2008-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients with STEMI<12 from synptoms onset
• eligble for primary PCI regardless of initial TIMI flow grade.
• patients for rescue PCI after failed thrombolysis will also be included

Exclusion Criteria

• womwn with known pregnancy or who are lactating
• pts with allergy to aspirin, clopidogrel or heparin
• inability to obtain informed consent
• known existence of life threatening diseases with a life expectency less than 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Limitation of infarct size
Early and follow up related (MACE)-major adverse cardiac events

Secondary Outcome Measures

Name	Time	Method
Efficacy of using aspiration device after every stage of Primary angiplasty

Trial Locations

Locations (1)

HaEmek Medical Center; 🇮🇱 Afula, Israel