Aspiration Device in Myocardial Infarction Trial

Aspiration Device Myocardial Infarction Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00370578

Enrollment

100

Registered

2006-08-31

Start date

2006-09-30

Completion date

2008-06-30

Last updated

2007-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angioplasty

Keywords

STEMI, THROMBUS, ASPIRATION DEVICE, NO REFLOW

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

Interventions

DEVICErepeated thrombus aspiration during primary PCI

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Limitation of infarct size	—
Early and follow up related (MACE)-major adverse cardiac events	—

Secondary

Measure	Time frame
Efficacy of using aspiration device after every stage of Primary angiplasty	—

Countries

Israel

Contacts

Primary ContactYOAV TURGEMAN, MD

yoav_t@clalit.org.il972-46494016

Backup ContactLIMOR ILAN- BUSHARI, MD

limor_il@clalit.org.il972-46495273

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026