Aspiration Device in Myocardial Infarction Trial

HaEmek Medical Center, Israel

Status

Unknown

Conditions

Angioplasty

Treatments

Device: repeated thrombus aspiration during primary PCI

Study type

Interventional

Funder types

Other

Identifiers

NCT00370578

Yoav Turgeman MD

HaE064990ctil

Details and patient eligibility

About

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.

Full 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:

Immediate angiographic differences between the study arms. By evaluation of: TIMI FLOW GRADE,TIMI FRAME COUNT,MYOCARDIAL BLUSH GRADE. No reflow phenomenae,
Infarc size evaluated by serum markers and non invasive parameters
In hospital major adverse cardiac events
Major adverse cardiac events during 30& 180 days of follow up

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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