Aspiration Device in Myocardial Infarction Trial

NCT ID: NCT00370578

Last Updated: 2007-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-06-30

Brief Summary

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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

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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

Conditions

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Angioplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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repeated thrombus aspiration during primary PCI

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Principal Investigators

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Yoav Turgeman, MD

Role: PRINCIPAL_INVESTIGATOR

Technion-school of medicine, Haifa, Israel

Locations

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HaEmek Medical Center

Afula, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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YOAV TURGEMAN, MD

Role: CONTACT

972-46494016 ext. 5264

LIMOR ILAN- BUSHARI, MD

Role: CONTACT

972-46495273 ext. 5273

Facility Contacts

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Khalid Suleiman, MD

Role: primary

972-46494017 ext. 4017

Alexander Feldman, MD

Role: backup

972-46495585

Other Identifiers

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Yoav Turgeman MD

Identifier Type: -

Identifier Source: secondary_id

HaE064990ctil

Identifier Type: -

Identifier Source: org_study_id