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Aspiration Device in Myocardial Infarction Trial

Primary Purpose

Angioplasty

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

repeated thrombus aspiration during primary PCI

About this trial

This is an interventional treatment trial for Angioplasty focused on measuring STEMI, THROMBUS, ASPIRATION DEVICE, NO REFLOW

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

HaEmek Medical CenterRecruiting

Outcomes

Primary Outcome Measures

Limitation of infarct size

Early and follow up related (MACE)-major adverse cardiac events

Secondary Outcome Measures

Efficacy of using aspiration device after every stage of Primary angiplasty

Full Information

NCT ID

NCT00370578

First Posted

August 9, 2006

Last Updated

August 27, 2007

Sponsor

HaEmek Medical Center, Israel

1. Study Identification

Unique Protocol Identification Number

NCT00370578

Brief Title

Aspiration Device in Myocardial Infarction Trial

Official Title

Aspiration Device Myocardial Infarction Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2006

Overall Recruitment Status

Unknown status

Study Start Date

September 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

HaEmek Medical Center, Israel

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Angioplasty

Keywords

STEMI, THROMBUS, ASPIRATION DEVICE, NO REFLOW

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

repeated thrombus aspiration during primary PCI

Primary Outcome Measure Information:

Title

Limitation of infarct size

Title

Early and follow up related (MACE)-major adverse cardiac events

Secondary Outcome Measure Information:

Title

Efficacy of using aspiration device after every stage of Primary angiplasty

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

YOAV TURGEMAN, MD

Phone

972-46494016

Ext

5264

yoav_t@clalit.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

LIMOR ILAN- BUSHARI, MD

Phone

972-46495273

Ext

5273

limor_il@clalit.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoav Turgeman, MD

Organizational Affiliation

Technion-school of medicine, Haifa, Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

HaEmek Medical Center

City

Afula

ZIP/Postal Code

18101

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Khalid Suleiman, MD

Phone

972-46494017

Ext

4017

sulieman_k@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Alexander Feldman, MD

Phone

972-46495585

feldman_a@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Shaul Atar, MD

First Name & Middle Initial & Last Name & Degree

Nahum A Freedberg, MD

12. IPD Sharing Statement

Learn more about this trial

Aspiration Device in Myocardial Infarction Trial

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